r. hahn—tricuspid interventions 10/11/2016 · r. hahn—tricuspid interventions 10/11/2016 13...
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Rebecca Hahn, MDProfessor of MedicineColumbia University
3/3/2018 8:10 AM‐8:30 AMCatheter‐based Interventions for the Tricuspid Valve
Core Lab Director for multiple tricuspid device trials for which I receive no direct compensation:
Other Disclosures: GE Medical: Speaker / Speaker's Bureau
Philips Healthcare: Speaker / Speaker's Bureau
Abbott Structural: Speaker / Speaker's Bureau
Gore and Associates: Consultant, Advisor
Boston Scientific: Speaker / Speaker's Bureau
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http://www.onlinejase.com/article/S0894‐7317(13)00562‐2/fulltext
TEE
Four Levels of Imaging for the Tricuspid Valve:1. Mid‐esophageal2. Deep‐esophageal3. Shallow Transgastric4. Deep Transgastric
3D Modalities:1. Simultaneous Multiplane2. Real Time 3D3. Full Volume 3D4. Zoom 3D5. Color 3D
Hahn RT et al. JASE 2013;26:921‐64
Deep Esophageal
New Level for Tricuspid Valve Imaging:
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Hahn RT J Am Soc Echocardiogr 2013;26:921‐64
Four Levels of Imaging Five probe manipulations: Five 3D Modalities
1. Mid‐esophageal2. Deep‐esophageal3. Shallow Transgastric4. Deep Transgastric
1. Advancing and withdrawing the probe
2. Turning probe (clockwise to the right chest, counter‐clockwise to the left chest)
3. Anteflexion and retroflexion (large “wheel”)
4. Right and left flexion (small “wheel”)
5. Mechanical rotation of the multi‐plane probe (0‐180)
1. Simultaneous Multiplane
2. Real Time 3D3. Full Volume 3D4. Zoom 3D5. Color 3D
Retroflexion Anteflexion
Right Flexion Left Flexion
Left+Ante Right+Ante
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Grasping view for P‐SGrasping view for A‐S
Slight ante‐flexion Slight retro‐flexion
Pacing wire in A‐S commissure
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AnteflexedRetroflexed
Septal
Anterior
Posterior
Pacing Wire
Pacing wire in A‐S commissure
AnteflexedRetroflexed
Septal
Anterior
Posterior
Pacing Wire
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ME Short‐Axis at Base/RV Inflow‐outfowSWEEP:
Septal‐Posterior Commissure
Septal‐Posterior Tips
Septal‐Anterior Commissure Septal‐Anterior Tips
A‐S Anterior CommissureA‐S CentralA‐P or A‐S Commissure
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Grasping view for A‐S (slight anteflex or higher esophageal view)
Grasing view for P‐S (slight retroflex or deeper esophageal view)
1. Eliminates LA from view2. Closer to TV
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Hahn RT et al. J Am Soc Echocardiogr 2013;26:921‐6
Transgastric Views of the RV and TV
Used to position Clip under valve and for clip arm perpendicularity
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LV
ARV
RA
All 3 leaflets imaged
SeptalAnteriorPosterior
BRV
RARA
RV
SeptalAnteriorPosterior
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KEY CAVEAT:
Three‐dimensional valve
Highly variable anatomy
Leaflet identification MUST be confirmed with 3D en face view
3D en face view
Use biplane views to check that the tricuspid valve annulus is centered within the acquisition plane
Rotate to the right atrial enface view
Rotate 90 to place the IAS at the 6 o’clock
position
Standard tricuspid valve view from the right atrial perspective
Standard tricuspid valve view from the right ventricular perspective
A B
CDE
PRESENTATION
ACQUISITION
AP
S
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Multi‐beat acquisition EVEN IN AFIBMay be still be accurate for the systolic time interval
Percutaneous Approachesfor Tricuspid Regurgitation
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Approaches:1. Superior vena cava2. Inferior vena cava3. Transapical4. Transatrial
Anatomic Target1. Leaflet 2. Annulus3. IVC4. Valve
Annular Devices
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Procedural Steps
•Right Internal Jugular Access
•Two 14F Sheaths
•Hook around wire delivery to deliver 1st pledget (anchor)
•Repeat wire delivery steps to deliver 2nd pledget(anchor)
•Cinch pledgets together to obliterate the posterior leaflet and deliver lock on atrial side
Note: Investigational Device
Wire across the tricuspid annulus: may need to help guide to avoid coronary sinus
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• Tricuspid Wire Delivery Catheter shaft in the correct position in the TV orifice with tip pointed toward the outside
1st Tricuspid Wire Delivery Catheter
A
PS
RA
RV
LA
RV
1st Tricuspid Wire Delivery Catheter Re‐positioning
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1st Tricuspid Wire Delivery Catheter Re‐positioning
Confirm annular depth(6 mm)
Image Wire Crossing
RA
RV
LA
During radiofrequency deployment, catheter moved
Position now too posterior (not at septal‐posterior commissure)
1st Tricuspid Wire Delivery Catheter
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Wire catheter too shallow
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Posterior Septal Location
3D: Visualize Wire Catheter Position
2D: Visualize Wire Catheter Depth
Depth: Distance from leaflet insertion point or hinge to the wire catheter or crossing wire
Increase Gain: to visualize leaflets
Decrease Gain: to visualize the catheter (exclude the leaflets)
RV RA
Wire catheter depth looks good
Pledget Deployment
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Second Wire Re‐Position x2
Distance 2.7 cm
Ideal Distance between pledgeted sutures: 2.4‐2.8 cm
Cinching‐‐Plicating
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Parameter Post
Tricuspid Annular Area
7.6 cm2
TricuspidValve Area 6.5 cm2
Tricuspid EROA 0.43 cm2
Tricuspid Regurgitant Volume
40 cc
Forward Stroke Volume
77 cc
PASP (mmHg) 58
PISA
Quantitative Doppler
3D EROA
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3D EROA3D Annulus
3D EROA3D Annulus
Baseline
Post‐Trialign
13.9 cm2
7.6 cm2
0.99 cm2
0.43 cm2
Hahn RT et al. J Am Coll Cardiol 2017;69:1795–806
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SCOUT I SCOUT II
ClinicalTrials.gov Identifier: NCT02574650
A prospective, single‐arm, multi‐center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left‐sided valve surgery is not planned.
The study will include up to 30 subjects from up to 6 sites in the US.
Follow‐up evaluations will be conducted through 2‐years post implantation.
ClinicalTrials.gov Identifier: NCT03225612
A prospective, single‐arm, multi‐center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation.
The study will include up to 60 subjects from up to 15 sites in Europe and the United States.
Follow‐up evaluations will be conducted through 5 years post implantation.
Leaflet Devices
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1. Identify the location of the target jet Comprehensive baseline imaging primarily utilizing 3D
2. Confirm 2D imaging planes for imaging the clip procedure3. Position the guide catheter4. Orient the clip arms5. Cross the TV annulus and re‐align the clip arms6. Grasp leaflets7. Perform full post‐clip assessment
Mean gradient Planimetered EOA (3D) Residual TR (3D)
Note: Off‐label Use
Largest jet between the posterior and septal leaflets
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Device Straddle and Steering
Bicaval 4Ch
En face view
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2D Imaging planes off‐axis 2D imaging Planes aligned with Clip Arms
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Grasping and Perpendicularity
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Spacer Positioned within regurgitant orifice Provides surface for native leaflets
to coapt 12, 15 and 18mm sizes Advanced from left subclavian vein
Rail Tracks Spacer into position Anchored at RV apex and
subclavian vein
Note: Investigational Device
Total Residual EROA = 0.74 cm2
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The FORMA TrialEarly Feasibility Study of the
Edwards FORMA Tricuspid Transcatheter
Repair System
N= 30
Adult subjects with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair
or replacement as assessed by the Heart Team
Primary Endpoint 30 daysAll‐Cause Mortality
6 Month and 1, 2, 3, YearClinical and Imaging Echo FUP
The SPACER TrialRepair of Tricuspid Valve
Regurgitation using the Edwards TricuSPid TrAnsCatheter REpaiR
System
N= 78
Adult subjects with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair
or replacement as assessed by the Heart Team
Primary Endpoint 30 daysAll‐Cause Mortality
6 Month and 1, 2, 3, YearClinical and Imaging Echo FUP
The Future:Transcatheter Tricuspid
Valve Replacement
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Components Specifications• Temperature Shape Memory NiTinol Tapered Stent
(Inflow=30mm/Outflow=40mm)• Height profile 21 mm, Truncated Cone configuration with a Diffuser effect.• Annular Winglets for secure anchoring of annulus and tricuspid valve leaflet. • Chemically Preserved Xenogeneic Pericardium.
The largersized valves are
idealfor the dilated
Tricuspid Valve. (TV 48 + 4mm Ø)
Note: Investigational Device
Delivery System Capsule profile: 35F Proximal Shaft: 24F Steerable distal shaft length:
2.5 cm Usable Length: 40 cm Steering control knob for
coaxial alignment Controlled Release Knob to
avoid jumping during device deployment
Introducer Sheath Sheath OD: 42F Sheath is radiopaque Triple valve for hemostasis
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Systolic phase:
44 x 54 mm
Diastolic phase
44 x 49 mm
Decision: 48 vs 52 mm valve
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Diastolic phase
43 x 45 mm
Plan for transcatheter tricuspid valve replacement with a 48mm NaviGate tricuspid valve bioprosthesis
EROA by PISA = 0.63cm2 and calculated regurgitation volume = 70.4cc
2D Quantitation: annular area = 13.8 cm2 calculated diastolic stroke volume = 156 cc,regurgitation volume = 106.8 cc, EROA = 0.96 cm2
3D Quantitation: annular area = 15.38cm2 (dimensions = 4.45cm by 4.28cm) calculated diastolic stroke volume = 173.8cc, regurgitation volume = 120.7cc, EROA =1.08cm2
3D color Doppler EROA (averaged over 11 frames) = 0.91cm2
calculated regurgitation volume = 101.6cc.
3D TV EOA = 7.50cm2
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Rebecca T. Hahn, and Jose L. Zamorano. “The Need for a New Tricuspid Regurgitation Grading Scheme.” European Heart Journal - Cardiovascular Imaging 2017
Severe Massive Torrential
Massive tricuspid incompetence
Temporary pacing achieved with Confida wire in left ventricle and pacing electrodes mounted on wire
Simultaneous Echo and FluoroGuidance is KEY
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Positioning the Transatrial Puncture
Atrial Poke: Distance 7.5 cm
Poor Position (non‐coaxial)
Good Position (coaxial)
Positioning of stiff guidewire into right ventricle over a pigtail catheter, and
through transatrial incision
Balloting the Atrium
Case 6: Columbia University 10/2017Initial valve deployment with RCA injection
Coaxial View 2 Short‐axis View
Retracting the capsule: Exposing Ventricular Tines
Coaxial View 1
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• Trivial central and trivial paravalvular regurgitation
• Peak/mean transtricuspid gradient = 1.5 and 0.3 mmHg
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TRANSCATHETER TECHNOLOGIES
Mechanism New Technologies
Annuloplasty(Direct and Indirect)
TriAlign Cardioband 4Tech Millepede Pasta
Leaflet Devices
Forma MitraClip PASCAL
Stented Valves in IVC/SVC
Trinity /Sapien TriCentro
Valve Replacement
Navigate