Bioprosthetic Valve Fracture To Optimize Results Following VIV TAVR

Keith B. Allen, MDClinical Associate Professor of Surgery, UMKC

Co Director of Structural HeartSt. Luke’s Mid America Heart Institute

Kansas City, Missouri

DisclosuresEdwards (Research, Proctor/Speaker’s Bureau)

Medtronic (Research, Speaker’s Bureau)Abbott (Research, Consulting)

The smaller the surgical valve, the higher the mortality!

1-Year Mortality After Valve-in Valve TAVRValve-in-Valve International Data (VIVID) Registry Dvir, et al. JAMA 2014

Impact of Residual Gradient on 1-Year Mortality

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

PARTNER ViV Study

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

‘Tricks’ to Optimize Results with VIV TAVR

Impact of Implantation Depth on Minimizing Residual Gradients

During VIV TAVRSimonato, et al. EuroIntervention 2016;12:909-917

Implant Depth

Optimal Implantation Depth: CoreValveSimonato, et al. EuroIntervention 2016;12:909-917

1-2 mm deep is the sweet spot

Optimal Implantation Depth: Sapien XT/S3Simonato, et al. EuroIntervention 2016;12:909-917

Sweet Spot is as Shallow as Comfort Allows

Rated for Mature Audiences Only

➢ Bench testing demonstrated BVF, when performed with a non-compliant balloon and high-pressure inflation, can fracture the surgical valve and allow further expansion of the THV

➢In early clinical experience, BVF resultedin reduced residual gradients and increased valve EOA following VIV TAVR

US Surgical Tissue Valves that can beFractured

Allen KB, Chhatriwalla A, et al. Ann Thorac Surg 2017;104:1501–8

Set up for BVF

3 41

2

Hand Inflation

Saxon JT, Allen KB, Cohen DJ, Chhatriwalla A. Bioprosthetic Valve Fracture (BVF): Bench to Bedside. Interventional Card Rev 2018;13(1):20–6.

Confirmation of FractureAny of the following

– The indeflator pressure drops (in the absence of balloon rupture)

– An audible snap

– The balloon waist releases – may be subtle

– Visual confirmation of the fractured ring may be difficult to detect in real time

BVF Balloon Position ImportantSevere AI related to detached leaflet from CoreValve frame

can occur with incorrect balloon position

Constrained Area

Constrained Area20 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

Some Valves Can Be Modified

Stretched

Some Valves Can Be Modified

Bent

PORTICO VALVE IN A REMODELED TRIFECTA GT

Presented at HVS Meeting 2018

Remodeled Trifecta following VIV with Corevalve

Some Valves Cannot Be Fractured or Modified

Richard Lee and Michael LimSaint 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. NguyenMemorial Herman – Texas Medical Center

Houston, TX

Keith B. Allen and Adnan ChhatriwallaSt. Luke’s Mid America Heart Institute

Kansas City, MO

Josh RovinMorton Plant Hospital

Tampa Bay, FL

Juhana KarhaAustin Heart

Austin, TX

Dennis J. Gory Peace Health Medical Group

Eugene, Oregon

Anthony BavryThomas BeaverAshkan Karimi

University of Florida Gainsville, FL

Brian WhisenantIntermountain Medical Group

Sandy, UT

Ed GarrettMemphis Baptist

Memphis, TN

Vinod ThouraniWashington Med Star Hospital

Washington DC

John Webb, Danny DvirUniversity of British Columbia

Vancouver, British Columbia, Canada

DW ParkAsian Medical Center

Seoul, South Korea

Pradeep YadavPenn State Hershey Medical Center

Hershey, PA

BVF performed in 75 patients at 21 centersMarch 2016 to April 2018

Alan Yeung Stanford University

Palo Alto, CA

Adam Greenbaum MD and William O’Neill MDHenry Ford Detroit Medical Center

Detroit, MI

Alex Pak, Zafir Hawa, James Mitchell North Kansas City Hospital

North Kansas City, MO:

Jason Ricci McLaren Northern MI Hospital

Petoskey, MI

Deutsches HerzzentrumBerlin, GermanyAxel Unbehaun

Largest BVF Series To Date➢ Surgical valves were categorized by their true internal diameter (ID) as

- Small (< 18.5 mm)- Intermediate (>18.5 to < 21 mm)- Large (> 21 mm)

➢ THV’s were categorized as either “right sized” or “up sized” based on whether the heart team selected a THV size equal to, or larger than, that recommended by the VIV App

➢ Non-compliant balloons used to perform fracture were categorized based on their size in comparison to true ID of the surgical valve being fractured

- Small if they were < 3 mm larger and large if they were >3 mm larger

METHODSInvasive hemodynamic measurements and calculation of the valve EOA were performed at

In patients that had BVF first only baseline and final gradients were obtained

Timing of BVF

BVF Complications

BVF Complications

◼ No coronary occlusions

◼ No annular ruptures (clinical or subclinical)

◼ No new pacemakers

◼ 95% (71/75) no AI

◼ 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

Residual Gradient BVF after VIV TAVR (n=66)

0

20

40

60

80

40.6 ± 16 p<0.001

8.1 ± 4.8

Baseline After VIV TAVR After BVF

19.0 ± 8.8

p<0.001

Mea

n R

esid

ua

l G

rad

ien

t (m

m H

g)

Final Mean EOABVF after VIV TAVR (n=66)

0

0.5

1

1.5

2

2.5

0.8 ± 0.3

p<0.001

2.1 ± 0.8

Baseline After VIV TAVR After BVF

1.4 ± 0.8

p<0.001

Mea

n V

alv

e E

OA

(cm

2)

Univariate Predictors of Best HemodynamicsUnivariate Associations

Variable Beta Weight (95% CI) p-value

THV Type 0.15 (-2.86, 3.16) 0.92

THV Right vs Up Sized -0.77 (-3.75, 2.21) 0.61

Surgical Valve True ID 3.23 (-3.40, 10.86) 0.40

Baseline Mean Gradient 0.06 (-0.04, 0.15) 0.24

Mode of Valve Failure -2.35 (-8.28, 3.58) 0.43

Large BVF Balloon Size 4.44 (0.57, 8.32) 0.03

Timing of BVF (BVF after VIV TAVR) 8.76 (4.74, 12.79) <0.001

Multivariable Predictors of Best HemodynamicsMultivariable Associations

Variable Beta Weight (95% CI) p-value

THV Type 0.53 (-2.78, 3.84) 0.75

THV Right vs Up Sized 0.64 (-3.07, 4.35) 0.73

Surgical Valve True ID 3.73 (-3.62, 11.08) 0.31

Baseline Mean Gradient 0.10 (-.003, .203) 0.052

Mode of Valve Failure -0.58 (-6.44, 5.28) 0.84

Large BVF Balloon Size 4.94 (1.09, 8.80) 0.013

Timing of BVF (BVF after VIV TAVR) 8.91 (4.64, 13.18) <0.0001

➢ Heavily calcified roots

➢ Intra rather then supra-annularly positioned surgical valves

19 mm Sorin Mitroflow

➢ Heavily calcified roots

➢ Intra rather then supra-annularly positioned surgicalvalves

➢ Chimney roots with effaced or absent sinus that don’t have room for valve expansion

➢ Coronary occlusion

CONCLUSIONS

➢BVF can be performed safelyand results in reducedresidual gradients andincreased valve area

➢ Lots still to learn

Univariate Predictors of Best Hemodynamics

To Be Continued

Multivariable Predictors of Best HemodynamicsMultivariable Associations

Variable Beta Weight (95% CI) p-value

THV Type 0.53 (-2.78, 3.84) 0.75

THV Right vs Up Sized 0.64 (-3.07, 4.35) 0.73

Surgical Valve True ID 3.73 (-3.62, 11.08) 0.31

Baseline Mean Gradient 0.10 (-.003, .203) 0.052

Mode of Valve Failure -0.58 (-6.44, 5.28) 0.84

Large BVF Balloon Size 4.94 (1.09, 8.80) 0.013

To Be Continued