bioprosthetic valve fracture (bvf) to facilitate viv-tavr · bioprosthetic valve fracture (bvf) may...
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Bioprosthetic Valve Fracture (BVF) to Facilitate VIV-TAVR
Keith B. Allen MD Department of Cardiothoracic & Vascular Surgery
Saint Luke’s Mid America Heart Institute Kansas City, MO USA
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Edwards (PARTNER, S3, Speaker’s Bureau)
Medtronic (SURTAVI, Speaker’s Bureau) Abbott (PORTICO)
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Current Indications for TAVR: Just the Tip of the Iceberg
STS database 2002-2010 (141,905 pts)
6.2% High Risk (STS > 8%)
13.9% Intermediate Risk (STS 4- 8%)
79.9% Low Risk (STS < 4%)
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VIV TAVR is not the Same Procedure!
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VIV TAVR carries different technical and procedural concerns such as coronary occlusion
Currently only approved for high-risk or inoperable patients
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Explanted 23 S3 VIV in a 21 Magna Ease after only two years
Durability of VIV TAVR UNKNOWN!
Transcatheter valves placed VIV are by definition constrained and not optimally expanded and the effect on durability is unknown
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VIV TAVR is an effective alternative to redo surgery and approved for high risk patients with failing tissue valves. VIV TAVR, however, can be problematic with small surgical bioprostheses because of further reduction in the effective orifice leading to high residual gradients.
Valve-in Valve TAVR
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The smaller the surgical valve, the higher the mortality!
1-Year Mortality After Valve-in Valve TAVR Valve-in-Valve International Data (VIVID) Registry Dvir, et al. JAMA 2014
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Impact of Residual Gradient on 1-Year Mortality
Webb J, et al. JACC 2017; 69:2253-62
PARTNER ViV Study
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‘Tricks’ to Optimize Results with VIV TAVR
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Impact of Implantation Depth on Minimizing Residual Gradients
During VIV TAVR
Simonato, et al. EuroIntervention 2016;12:909-917
Implant Depth
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Implantation Depth: CoreValve
Simonato, et al. EuroIntervention 2016;12:909-917
1-2 mm deep is the sweet spot
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Implantation Depth: Sapien XT
Simonato, et al. EuroIntervention 2016;12:909-917
Sweet Spot is as Shallow as Comfort Allows
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Bioprosthetic Valve Fracture (BVF) to Facilitate and Optimize VIV TAVR
Allen KB, Chhatriwalla A, et al. Ann Thorac Surg 2017;104:1501–8
Which valves can be fractured? What balloons work?
What balloon pressures are required for each valve to be fractured?
Does surgical valve fracture allow transcatheter valves to expand optimally?
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TRU DILATION and ATLAS GOLD high-Pressure balloons 1 mm larger than labeled valve size were tested on 19 & 21 mm tissue valves
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21mm Magna fractured with 22mm TRU Balloon
Bench Testing
Allen KB, Chhatriwalla A, et al. Ann Thorac Surg 2017;104:1501–8
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US Surgical Tissue Valves that can be Fractured
Allen KB, Chhatriwalla A, et al. Ann Thorac Surg 2017;104:1501–8
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Some Valves Cannot Be Fractured
Medtronic Avalus
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In an unfractured 21 mm Magna with a true ID of 19 mm, the 23mm Evolut R is constrained to 19 mm
and not optimally expanded
Following BVF, the true ID of the 21 mm Magna increases 4 mm and the 23mm Evolut R is now
optimally expanded
BVF Optimizes Expansion of Self Expanding Transcatheter Valves
Allen KB, Chhatriwalla A, et al. Ann Thorac Surg 2017;104:1501–8
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BVF Optimizes Expansion of Balloon Expandable Transcatheter Valves
In an unfractured 21 mm Magna with a true ID of 19 mm, the 23 mm XT is constrained to 19 mm and not
optimally expanded
Following BVF, the true ID of the 21 mm Magna increases 4 mm
and the 23 mm XT is now optimally expanded
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Set up for BVF Saxon JT, Allen KB, Cohen DJ, Chhatriwalla A. Bioprosthetic Valve Fracture (BVF): Bench to Bedside. Interventional Card Rev (in press).
3 4 1
2
Hand Inflation
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We recommend TAVR first then BVF
We typically use a balloon 1 mm larger then the labeled valve size
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We recommend TAVR first then BVF
We typically use a balloon 1 mm larger then the labeled valve size
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Early Clinical Experience 10 US Centers/30 patients
0
20
40
60
80
Me
an G
rad
ien
t (m
mH
g)
43 ± 8
20.4 ± 8 Severe PPM
8 ± 5
P<0.001
P<0.001
STS 2018, Poster #20
* For pts treated with BVF after ViV TAVR
Baseline Post VIV TAVR After BVF
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Early Clinical Experience 10 US Centers/30 patients
STS 2018, Poster #20
0.0
0.5
1.0
1.5
2.0
2.5
0.6 ± 0.2
1.1± 0.7
2.0 ± 0.7 P<0.001
P<0.001
Ao
rtic
Val
ve A
rea
(cm
2)
* For pts treated with BVF after ViV TAVR
Baseline Post VIV TAVR Post BVF
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Richard Lee Michael Lim
Saint Louis University St. Louis, MO
Brian W. Hummel Lee Memorial Hospital
Fort Myers, FL
Mark J. Russo, Bruce J. Haik Newark Beth Israel Medical Center
Newark, NJ
Pranav Loyalka, Tom C. Nguyen Memorial Herman – Texas Medical Center
Houston, TX
Keith B. Allen Adnan Chhatriwalla
St. Luke’s Mid America Heart Institute Kansas City, MO
Josh Rovin Morton Plant Hospital
Tampa Bay, FL
Juhana Karha Austin Heart
Austin, TX
Dennis J. Gory Peace Health Medical Group
Eugene, Oregon
Anthony Bavry Thomas Beaver Ashkan Karimi
University of Florida Gainsville, FL
Brian Whisenant Intermountain Medical Group
Sandy, UT
Ed Garrett Memphis Baptist
Memphis, TN
Vinod Thourani Washington Med Star Hospital
Washington DC
John Webb, Danny Dvir University of British Columbia
Vancouver, British Columbia, Canada
DW Park Asian Medical Center
Seoul, South Korea
Pradeep Yadav Penn State Hershey Medical Center
Hershey, PA
BVF Registry Sites
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BVF Complications
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BVF Complications
2 minor strokes no residual
1 chordal tear moderate-severe MR treated with MitraClip
2 severe AI from disruption of TAVR valve treated successfully
with second valve-in-valve
In-hospital/30-day mortality 1.5% (1/65)
No coronary occlusion
No annular rupture (clinical or subclinical)
No new pacemakers
94% (61/65) no AI
* 65 cases in full series as of 1/2018
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BVF Balloon Position Important Severe AI related to detached leaflet from CoreValve frame
may be prevented by correct balloon position
Constrained Area
Constrained Area 20 mm
22 mm 23 mm
BVF balloon should not be more then 2 mm larger then CV constrained area Allen KB, Chhatriwalla A, et al. Ann Thorac Surg 2017;104:1501–8
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Balloon Expandable Valves Need to be Post Dilated with High Pressure Inflation Following BVF to
Optimize Expansion
Edwards 23 mm XT Expanded Nominally
VIV TAVR in 21 Magna Prior to BVF
Following BVF Following High Pressure Post Dilation
Allen KB, Chhatriwalla A, et al. Ann Thorac Surg 2017;104:1501–8
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Heavily calcified roots
Intra rather then supra- annularly positioned surgical valves
Chimney roots with effaced or absent sinus that don’t have room for valve expansion Coronary occlusion
19 mm Sorin Mitroflow
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Inspiris Surgical Tissue Valve
Expansion zone
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Inspiris Surgical Tissue Valve
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Bioprosthetic Valve Fracture (BVF)
May offer a “solution” to high residual gradients after VIV TAVR and improve short and long term outcomes
BVF is generally safe (although not entirely risk-free)
Many unresolved questions that require further study
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 which may improve durability
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