intraprocedural imaging of transcatheter tricuspid valve...

J A C C : C A R D I O V A S C U L A R I M A G I N G V O L . 1 2 , N O . 3 , 2 0 1 9

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P U B L I S H E D B Y E L S E V I E R

STATE-OF-THE-ART PAPER

Intraprocedural Imaging of TranscatheterTricuspid Valve Interventions
Rebecca T. Hahn, MD,a Michael Nabauer, MD,b Michel Zuber, MD,c Tamim M. Nazif, MD,a Jörg Hausleiter, MD,b
Maurizio Taramasso, MD, PHD,c Alberto Pozzoli, MD,c Isaac George, MD,a Susheel Kodali, MD,a Vinayak Bapat, CTH,a

Francesco Maisano, MDc

ABSTRACT

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Interest in the transcatheter solutions for tricuspid regurgitation has gained momentum given the limited indications

for and high in-hospital mortality associated with isolated surgical intervention. Advanced imaging techniques to

guide the procedures are the key to technical success. The following overview of the imaging requirements of

selected devices is intended to give a glimpse into the complex procedures now possible with imaging guidance.

(J Am Coll Cardiol Img 2019;12:532–53) © 2019 by the American College of Cardiology Foundation.

I nterest in the transcatheter solutions fortricuspid regurgitation (TR) has increased inrecent years with the recognition of the impact

of secondary TR on outcomes (1–4) and the high in-hospital mortality associated with isolated tricuspidvalve (TV) surgery (5,6). A number of devices toaddress symptomatic severe TR are in early develop-ment or in trials with 1 device, the Cardioband(Edwards Lifesciences, La Jolla, California), receivingthe Conformité Européene (CE) mark award in April2018. Transcatheter TV devices currently underinvestigation or development (Table 1) can beroughtly divided into those treating annular dilata-tion (i.e., Trialign [Mitralign, Tewksbury, Massachu-setts], Cardioband [Edwards Lifesciences, Irvine,California], TriCinch [4TECH, Galway, Ireland], Milli-pede [Boston Scientific Corp., Marlborough,

N 1936-878X/$36.00

m the aColumbia University Medical Center, New York Presbyterian Hosp

liklinik I, Klinikum der Universität, Munich, Germany; and the cHeart Cen

rich, Switzerland. Dr. Hahn is the principal investigator for the SCOUT tria

entific Officer for the Echocardiography Core Laboratory at the Cardiovasc

ect industry compensation; and has received personal fees from Abbott V

althcare, and Siemens Healthineers. Dr. Nabauer has received personal

rsonal fees from Edwards Lifesciences, Boston Scientific, and Medtron

bott Vascular and Edwards Lifesciences. Dr. Taramasso has received pe

eived personal fees from Duna Biotech, Thubrikar Aortic Valve Inc., C

pat has received personal fees from Medtronic and Edwards Lifesciences

m Abbott, Edwards Lifesciences, Medtronic, and Boston Scientific; and

orted that they have no relationships relevant to the contents of this pap

nuscript received June 12, 2018; revised manuscript received July 24, 20

Massachusetts], and Cardiac Implants [Cardiac Im-plants LLC, Tarrytown, New York]), those approach-ing leaflet malcoaptation (i.e., MitraClip [AbbottVascular, Santa Clara, California], PASCAL [EdwardsLifesciences], and FORMA [Edwards Lifesciences]),heterotopic valve implantation (i.e., CAVI [cavalvalve implants] [Tricentro, New Valve Technology,Muri, Switzerland] and Tricentro), and transcatheterTV replacements (i.e., GATE, NaviGate Cardiac Struc-tures [Lake Forest, California], Trisol [Trisol Medical,Yokneam, Israel], valve-in-valve [ViV]). These de-vices use different access sites to reach the TV: thesuperior vena cava (SVC), inferior vena cava (IVC),and transtrial. Other devices in development may ac-cess the pericardial space. This list is not exhaustivebecause there is ongoing development of newdevices.

https://doi.org/10.1016/j.jcmg.2018.07.034

ital, New York, New York; bMedizinische Klinik und

ter, Zürich University Hospital, University of Zürich.

l for which she receives no compensation; the Chief

ular Research Foundation for which she receives no

ascular, Boston Scientific, Bayliss, Navigate, Philips

fees from Abbott Vascular. Dr. Nazif has received

ic. Dr. Hausleiter has received personal fees from

rsonal fees from Abbott and 4Tech. Dr. Kodali has

laret Medical, Meril Lifesciences, and Abbott. Dr.

. Dr. Maisano has received grants and personal fees

is a cofounder of 4Tech. All other authors have

er to disclose.

18, accepted July 25, 2018.

https://doi.org/10.1016/j.jcmg.2018.07.034

http://crossmark.crossref.org/dialog/?doi=10.1016/j.jcmg.2018.07.034&domain=pdf

AB BR E V I A T I O N S

AND ACRONYM S

2D = 2-dimensional

3D = 3-dimensional

CDS = clip delivery system

MSCT = multislice computed

tomography

RA = right atrial

RV = right ventricular

TEE = transesophageal

echocardiography

TR = tricuspid regurgitation

TV = tricuspid valve

VIV = valve-in-valve

J A C C : C A R D I O V A S C U L A R I M A G I N G , V O L . 1 2 , N O . 3 , 2 0 1 9 Hahn et al.M A R C H 2 0 1 9 : 5 3 2 – 5 3 Tricuspid Valve Interventions

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Pre-procedural planning typically requires a mul-timodality approach including transthoracic andtransesophageal echocardiography (TEE), multislicecomputed tomography (MSCT), and occasionally car-diac magnetic resonance (CMR) imaging. A brief re-view of important anatomy and use of multimodalityimaging is included; however, this review will focuson intraprocedural imaging. Six procedures exem-plify some of the imaging successes and challenges inthis field (Central Illustration): 2 annuloplasty devices(Trialign and Cardioband), 2 leaflet devices (the edge-to-edge leaflet repair and the FORMA), transcathetertricuspid replacement device (GATE valve), andtranscatheter tricuspid ViV procedure. The 2 annulardevices require different imaging skills to identify thetricuspid annulus and implant a device eitherthrough the annulus alone, or into the underlyingmyocardium. The 2 leaflet devices require preciseimaging of the tricuspid leaflets or precise implanta-tion of an anchor into the right ventricular (RV)myocardium. The 2 replacement devices require im-aging of valve positioning within the native TVannulus or a bioprosthetic TV. As new devicesand new imaging tools (i.e., large field-of-view3-dimensional [3D] intracardiac echocardiographiccatheters and multivendor fusion imaging) aredeveloped, intraprocedural imaging protocols willcontinue to evolve.

TV ANATOMY AND

PRE-PROCEDURAL IMAGING

An understanding of TV anatomy is essential forintraprocedural imaging of transcatheter devices (7).The relevant considerations are listed in Table 2.

Pre-procedural imaging of the right heart and TVby echocardiography, MSCT, and CMR are used toassess TV morphology, assess RV and left ventric-ular (LV) size and function, precisely define thetricuspid annulus and its relationship to adjacentstructures (i.e., right coronary artery [RCA]), char-acterize the vena cavae (for access or device im-plantation), identify the location and complexity ofthe subvalvular apparatus, as well as quantifyingregurgitation. Specific structural imaging is depen-dent on the device. For the annular devices, thearea and perimeter of the annulus, as well as thedepth of the annular tissue (from leaflet hinge-pointto RCA) are important measurements for sizing,positioning, and avoiding complications. For theedge-to-edge device, pre-procedural MSCT and CMRare not typically performed. In addition to theaforementioned anatomy, for the FORMA device,imaging is used to measure the distance from the

valvular annulus to the right ventricularapex and a target anchoring site is selectedbased on a sagittal TV imaging planes onMSCT reconstruction (8). For transcathetertricuspid replacement, sizing algorithmscontinue to be developed; however, 3D TEEand MSCT imaging have both been used toassess the average annular diameter (basedon perimeter as well as area) with minimaloversizing required given the conical shapeof the device and presence of an atrial brim.Selected patients may undergo pre-opera-tive imaging for tricuspid ViV. MSCT imag-ing may be particularly helpful inconfirming the size of an existing bio-
prosthesis. MSCT and CMR may also be useful inevaluating the cardiac structures, the feasibility ofvarious possible access routes, and the orientationof the TV plane with respect to the planned access.
TRIALIGN TV ANNULOPLASTY

DEVICE OVERVIEW. The Trialign system (MitralignInc., Tewksbury, Massachusetts) attempts to replicatethe results of the classic or modified Kay bicuspid-ization procedure (9,10). The Percutaneous TricuspidValve Annuloplasty System (PTVAS) for SCOUT(Symptomatic Chronic Functional Tricuspid Regurgi-tation) trial was the first U.S. prospective, single-arm,multicenter, early feasibility study to complete its 15patient enrollment and report the 30-day result(NCT02574650) (11). The Trialign device achieved: 1)93% procedural success, no procedural mortality orstroke, successful delivery and retrieval of the devicedelivery system, and proper placement of the devicein all patients; 2) quantitative reduction of tricuspidannular measurements and TR severity withconcomitant increase in LV forward stroke volume;and 3) improvement in quality of life measures. TheTrialign system uses a transjugular approach tointroduce a deflectable guide and wire deliverycatheter beneath the annulus. A pair of pledgetedsutures are implanted across the posterior leafletannulus and the 2 sutures drawn together to achieveplication of the annulus with reduction of TR ach-ieved by improving the coaptation of the anteriorleaflet and septal leaflets.

PROCEDURAL IMAGING. Pre-procedural imaging in-cludes a combination of transthoracic and TEE as wellas MSCT to evaluate the tricuspid annular shelf andRV morphology. Subannular myocardial bridges orshallow annular shelf (<2 to 4 mm) may make theimplantation difficult or result in device detachment.Implantation of the Trialign device relies primarily on

https://clinicaltrials.gov/ct2/show/NCT02574650

TABLE 1 Table of Transcatheter Tricuspid Valve Devices

Device Name Construction Status International Description

Trialign SCOUT I (US EFS trial) completed enrollmentof 30 patients.

SCOUT II (CE mark trial) enrolling.

Involves delivery of polyester pledgets via right internaljugular approach

The pledget is a polyester implant with a suture attachedthat serves as a suture buttressed anchor for plicationof the annulus.

A stainless steel lock tracks over the sutures and onceadequate plication is achieved, locks the pledgetedsutures together.

Cardioband CE mark awarded April 2018US EFS trial enrolling.

Adjustable, sutureless annuloplasty band of polyesterfabric through which stainless steel anchors(6 � 2.5 mm) are inserted.

Implanted through the transfemoral routeDesigned to reduce the septolateral annular diameter.

Tricinch Coil4Tech

CE Mark trial ongoing in Europe and Australia. Anteroposterior annuloplasty solutionCoil anchor design provides significant surface area to

distribute tensioning force with hemostatic forcesTransfemoral accessStent deployed in IVC to anchor tension device.

Millepede FIM implant in tricuspid position performedunder direct surgical view.

Adjustable complete annular ring.

PASTA Preclinical experience. Transannular pledgeted sutures to performanteroposterior annular plication (double orificevalve).

Transjugular access.

Cardiac Implants A First in Human Study to Assess Safety andPerformance of the DaVingi TR System inthe Treatment of Patients with FunctionalTricuspid Regurgitation.

Currently enrolling:Israel

Czech Republic

Spain (IRB pending)

Additional sites to be added in EUUS EFS planned for 2018

Complete flexible ring deployed around the valve annulususing a proprietary ring delivery scaffold system.

Tissue healing creates bonds with barbed anchors tosecure implant from dehiscence before loads areapplied.

Target predictable and reliable circumferential annularreduction with adaptable band.

Tricuspid ValveRepair System(TVRS)

TRILUMINATE is enrolling in both US andEurope.

The TVRS configuration consists of 2 parts: 1) a ClipDelivery System, which includes an implantable Clip(MitraClip NT device), a Steerable Sleeve and aDelivery Catheter; and 2) a Steerable Guide Catheterwhich includes a dilator.

The implantable clip is fabricated with metal alloys andpolyester fabric that are commonly used incardiovascular implants.

PASCAL Compassionate cases performed in tricuspidposition

Feasibility trial in mitral position ongoing.

Independent leaflet clasping system to performtranscatheter edge-to-edge.

Transfemoral route.

FORMA EFS of the Edwards FORMA TricuspidTranscatheter Repair System completed

Device redesign.

Spacer is positioned within regurgitant orifice and providesa surface for native leaflets to coapt.

Advanced from left subclavian veinRail tracks the Spacer into positionAnchored at RV apex and subclavian vein.

Continued on the next page

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TABLE 1 Continued

Device Name Construction Status International Description

Cavi FIM study completedOngoing trial in US and Europe.

2 self-expanding percutaneous heart valves were custom-made to provide 10% to 20% oversizing of the SVCand IVC (TricValve).

Bicaval Vs IVC only possible.The IVC valve protrudes into the RA, preventing backflow

while avoiding obstrucion of the HV.The SVC valve is funnel-shaped, with a skirt covering the

entire base of the valve to prevent paravalvularleakage.

Same approach using off-label TAVR aortic prostheses.

Tricentro FIM implant performed. Heterotopic valve implantation to reduce backflow in thevenous system.

Navigate 18 compassionate- use cases performedEFS in the US planned for late 2018.

Temperature Shape Memory NiTinol Tapered Stent(inflow ¼ 30 mm/outflow ¼ 40 mm)

Up to 54-mm size available.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 (equine) pericardium.

Trisol Advanced preclinical stage. Sail-like pericardial leaflets enable larger RV closingvolume with RV pressure relief and functionpreservation.

Simple and intuitive positioning and anchoring through a30-Fr delivery system with optional repositioning/retrieval.

Tricuspid Valve-in-Valve andValve-in-Ring

178 case reports from the VIVID Registry(156 VIV; 22 VIR).

Mostly performed through femoral route; jugular andtransatrial have been also reported

Sapien XT, Sapien 3, and Melody usedPVL common after VIR.

CE ¼ Conformité Européene; EFS ¼ early feasibility study; EU ¼ European Union; FIM ¼ first-in-man; IVC ¼ inferior vena cava; HV ¼ hepatic vein; IRB ¼ Institutional Review Board; PASTA ¼ Pledget-AssistedSuture Tricuspid Annuloplasty; PVL ¼ paravalvular leak; RA ¼ right atrium; RV ¼ right ventricular; SCOUT ¼ Symptomatic Chronic Functional Tricuspid Regurgitation trial; SVC ¼ superior vena cava; TAVR ¼transcatheter aortic valve replacement; TRILUMINATE ¼ Trial to Evaluate Treatment with Abbott Transcatheter Clip Repair System in Patients with Moderate or Greater Tricuspid Regurgitation; TR¼ tricuspidregurgitation; TVRS ¼ Tricuspid Valve Repair System; US ¼ United States; VIR ¼ valve-in-ring; VIVID ¼ Valve-in-Valve International Data.


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TEE (Table 3) (11). Before the implantation of thedevice, a guidewire is placed in the RCA to helpidentify its location relative to the tricuspid annulus.Two 14-F sheaths are introduced into the right ju-gular vein for delivery of the device. A deflectableguide catheter is introduced to position a wire de-livery catheter beneath the annulus, between the

posterior and septal tricuspid leaflet commissures.Before crossing the annulus, both 2-dimensional (2D)and 3D TEE imaging is used to visualize the wiredelivery catheter and confirm: 1) adequate annulardepth, (>2 to 4 mm from the hinge of the leaflet); 2)distance from the RCA; and 3) direction (into the rightatrium). An insulated radiofrequency (20 to 30 W for

CENTRAL ILLUSTRATION Intraprocedural Imaging for Transcatheter Tricuspid Valve Devices

Hahn, R.T. et al. J Am Coll Cardiol Img. 2019;12(3):532–53.

Intraprocedural imaging for various devices currently under investigation rely heavily on 2-dimensional (2D) and 3-dimensional (3D) echocardiography for guidance.

The 6 procedures reviewed exemplify some of the imaging successes and challenges in this field: (A to D) Trialign; (E, F) Cardioband; (G) the edge-to-edge leaflet

repair; (H) the FORMA device; (I) GATE transcatheter replacement device; and (J, K) transcatheter tricuspid valve-in-valve procedure.



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w3 s) wire is passed through the tissue of the annulusand wire position (both depth and location) isconfirmed by TEE. The wire is snared in the rightatrium, exteriorized, and a pledget delivery catheteris introduced over the wire and across the annulus.Fluoroscopy and TEE guide withdrawal of the pledgetdeliver catheter and seating of the RV side of thepledget. The proximal (atrial) side of the pledgetedsuture is deployed and cinched onto the annulus.After placement of the first pledget, a second wire is

positioned between 2.4 and 2.8 cm from the first site,near the commissure between the posterior andanterior TV leaflets (anteroposterior position), and asecond pledgeted suture is placed using the sametechnique. Theoretically, multiple pairs of pledgetsmay be implanted. If 2 pairs of pledgets are used,then the distance between the first pledget pair maybe less. A dedicated plication lock device is used tobring the 2 sutures together, drawing the ante-roposterior pledget toward the posteroseptal pledget.

TABLE 2 Anatomic Considerations for Surgical or Transcatheter Interventions

Intervention Type Interventional Considerations

Tricuspid leaflets and commissures

Large valve orifice (7-9 cm2, with mean gradient <2 mm Hg).

Usually 3 leaflets but variable (up to 6) or with deep clefts and folds.Very thin, translucent leaflets.

Anterior leaflet is typically the largest, with the greatest motion.Septal leaflet may be short radially, and is the least mobile.

Stenosis is unlikely with central orifice devices (i.e., edge-to-edge repair orspacer devices); however, mean gradients of >2 to 3 mm Hg may be significant.

Imaging leaflet anatomy may be challenging.

Imaging leaflet anatomy challengingLeaflets may not be ideal for anchoring devices.

High leaflet stress with greater leaflet motion.

Maneuvering to capture this leaflet may be difficult.

Chordae and papillary muscles

Anterior papillary muscle is largest, supplying chordal support to the anterior andposterior leaflets.

Anterior papillary muscle serves as an imaging landmark for these leaflets.

“Tenting” or tethering of the septal leaflet is common etiology of secondary TR,particularly if the septum is displaced toward the left ventricle.

Chordae may interact with catheters and devices.Marked tethering results from dilatation of the right ventricle or displacement ofpapillary muscles.

Septal leaflet chordae insert directly into septum or with multiple, small papillarymuscles.

Average of 25 chordae with varying configurations composed of straight collagenbundles (thus less distensible than mitral chordae).

Tricuspid annulus

D-shaped and flat along the septum.

Dynamic (larger in early diastole, and atrial systole).Average perimeter ¼ 12 � 1 cmAverage area ¼ 11 � 2 cm2.Heterogeneity in muscle and fatty tissues with discontinuous fibrous support.

Dilatation in disease states occurs along the unsupported lateral and posteriorfree wall portion of the annulus with more planar, circular shape.

Dynamic changes in shape should be preserved following device placement.

In the setting of dilatation, large annular devices may be required.

Stability of annular anchoring systems may vary along the circumference of theannulus.

Structures adjacent to the tricuspid valve

Right atrium is thin-walled, markedly dilated in advanced disease. Large space to maneuver devices but more difficult for imaging.

SVC ¼ mean length w7 cm, maximum diameter w2 cm, irregular in shape.IVC ¼ largest vein in the body (normally <21 mm).

Venous access considerations for new devices may be limited by SVC diametersand nonlinear shape. IVC-annular angle may pose issues for device placement.

Coronary sinus enters right atrium at the commissure between the septal andposterior leaflet.

Inflow of the coronary sinus is a good anatomic marker of this commissure.

Little risk for outflow tract obstructionShort (w3 to 4 mm) transverse distance along the inferior annulus (adjacent tothe posterior leaflet).

Risk for heart block with devices in this region.Risk for perforation with devices in this regionAortic sinuses of Valsalva may be used as an anatomic marker for the septal-anterior commissure.

No continuity between inflow and outflow

Right coronary artery within the AV groove (variable transversedistance from annulus).

AVN, Bundle of His crosses the septal leaflet attachment 3 to 5 mm posteriorto the anteroseptal commissure.

Noncoronary sinus of Valsalva borders the anterior/superior annulus (commissurebetween the noncoronary/right coronary sinuses adjacent to the septal/anteriortricuspid leaflet commissure).

Reproduced with permission from Dahou et al (7).

AV ¼ atrioventricular; AVN ¼ atrioventricular node; TR ¼ tricuspid regurgitation; other abbreviations as in Table 1.


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On fluoroscopic and TEE imaging, maximal plicationof the tricuspid annulus is performed. A completionRCA angiogram is performed after implantation.Multiple different conformations of pledgets can beused mimicking either the classic Kay (parallel su-tures) or the modified Kay (running mattress suture)procedures.CARDIOBAND TV RECONSTRUCTION SYSTEM

DEVICE OVERVIEW. The Edwards CardiobandTricuspid Valve Reconstruction System (EdwardsLifesciences, Irvine, California) device has been suc-cessfully used to treat severe functional TR (12,13).The Cardioband Tricuspid System is a device thatrepairs the TV and enables individualized reductionof the annulus to a more functional state.The Cardioband transcatheter device is delivered

transfemorally through the right atrium. The device isimplanted on the tricuspid annulus with anchorsinserted through the annulus and into the basal RVmyocardium. The device thus conforms to the naturalshape of the anatomy. After implantation, the deviceis contracted or cinched during continuous TEEguidance to reduce the septolateral diameter of thetricuspid annulus and improve leaflet coaptationunder beating heart conditions with real-timeconfirmation of TR reduction. Cardioband offers anovel annuloplasty option for patients with signifi-cant functional TR, who are inoperable, or who are athigh surgical risk. The Edwards Cardioband TricuspidValve Reconstruction System Early Feasibility Study(NCT03382457) has begun U.S. enrollment.PROCEDURAL IMAGING. Pre-procedural preparationincludes a combination of transthoracic and TEE and

https://clinicaltrials.gov/ct2/show/NCT03382457



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MSCT of the tricuspid annulus to evaluate leafletmorphology, RV function, and pulmonary arterypressure (Table 3). These imaging studies are neces-sary to exclude patients with annular calcification thatwould preclude proper placement of the Cardiobandimplant, and severe left heart pathologies. Trans-catheter left- and right-heart catheterization is per-formed before the implantation as necessary based onpatient history. The 25-F steerable Cardioband sheathis introduced over a Super-Stiff guidewire (Amplatzer,Boston Scientific, Marlborough, Massachusetts) intothe right atrium via the right femoral vein and the IVC.The implant catheter, with the Cardioband implantmounted on the distal end, is introduced for implan-tation. For orientation and safety reasons, a coronarywire is placed in the RCA, which becomes also a fluo-roscopic marker of the TV annulus, especially at theanterior and lateral region.

The Cardioband Tricuspid System requires anintegration of fluoroscopy and TEE as intraproceduralguidance (Table 4). More recently, 3-dimensionalintracardiac echocardiography has also been used forintraprocedural guidance. The fluoroscopic imagingrelies on 2 projections which are patient-specific andcan be easily calculated from the pre-proceduralMSCT scan. The first 1 is directed along the long-axis of the RV, aiming to show a perpendicular viewof the TV plane (usually a right anterior oblique viewor “RAO/CRA”). This view is used to assess the de-vice’s trajectory and the coaxiality with the tricuspidannulus. Moreover, it is used to check the properadvancement of the anchors. The simultaneous 3DTEE view helps obtain a spatial vision of the TVannulus, the leaflets, and the atrial wall.

The second fluoroscopic projection is the en faceview (usually a left anterior oblique caudal view or“LAO/CAU”) of the TV, in which the valve area can befully evaluated looking from the RV side (14). Thisprojection is useful to navigate the catheter to thetarget and is the same view as the 3D echocardiogra-phy en face, seen from the RV.

Regarding 3D TEE guidance, a surgical atrial view isfirst used to navigate the Cardioband towards theannulus, while the anchors are deployed undersimultaneous multiplane 2D view, to assess the cor-rect distance of the hinge point and correct angle ofimplantation with respect to the tricuspid annulus. Inselected cases with suboptimal echocardiographicwindow, use of intracardiac echocardiography (ICE)may also be used with TEE to visualize the annularhinge point.

The delivery catheter with the anchors is advancedfrom the aortic side around the anterior annulus to theposterior tricuspid annulus at the ostium of the

coronary sinus. To avoid tissue injury, manipulation ofthe TEE probe should be kept to a minimum. Becauseeach patient’s native anatomy is unique, 2D and 3Dechocardiography may be best performed from atransesophageal or from a transgastric approach toappropriately guide the implantation of the anchors.

After the anchors are placed sequentially on thenative annulus, the Cardioband Tricuspid System isprogressively contracted, reducing the septolateraland the anteroposterior TV diameter. With TEEguidance, further adjustments are performed tooptimize reduction in tricuspid regurgitation. Finally,a coronary angiogram is performed to check RCApatency.

EDGE-TO-EDGE TRICUSPID VALVE REPAIR

DEVICE OVERVIEW. Edge-to-edge repair hasemerged as the most frequently performed interven-tional procedure for severe mitral regurgitation,mostly using the MitraClip device (Abbott Labora-tories, Abbott Park, Illinois). Although the anatomy ofthe TV is much more complex, edge-to-edge repair hasbeen successfully performed for TR reduction (15).Currently available devices require special consider-ation in steering to allow perpendicular access to theTV annulus and adequate grasp of 2 leaflets (16).

PROCEDURAL IMAGING. TEE imaging of the TV ismuch more demanding than the mitral side due tolimited echocardiographic windows, shallow anglesof insonation, and shadowing by mitral and aorticvalve structures, especially when calcified or in thepresence of prosthetic valves. It is therefore manda-tory to ensure appropriate visibility of the TV leafletsin a careful pre-procedural TEE including a supinepatient position. Patients without adequate TV visi-bility should not be selected for TV edge-to-edgetreatment. In patients with primary TR, the underly-ing valve pathology must be clearly visualized duringpre-procedural TEE imaging. Essential windows forprocedural guidance of TV edge-to-edge repair aretransgastric and deep- or mid-esophageal windows(Table 5). High-quality multiplane TEE imaging isessential for assessment of the complex leaflet anat-omy and regurgitant jets, and visualization of thegrasping process.

Location of the regurgitant orifice and identifica-tion of the mal-coapting leaflets should be performedusing a multiwindow approach. From mid-esophagealviews, one of the most useful imaging techniques is touse the 60� to 80� imaging plane which spans theseptal leaflet (from posterolateral to anteromedialadjacent to the aortic valve). This view is the“commissural” view, and when used as the primary

TABLE 3 Summary of Intraprocedural TEE Imaging Recommendations for Trialign

Procedural Step Imaging Recommendations Imaging Example Caveats

1. Visualize guidedelivery system.

EchoImage introduction of Guideinto RA over TV annulus andwire into the RV.

Figure 1: Red arrows show the wire crossing into the RV.

2D and 3D imaging essential.Mid-esophageal and deep-esophageal views

helpful.

2. Visualize wiredelivery catheter.

Echo:a. Confirm position on theannulus at the septoposteriorcommissure.

b. Assess annular tissue depthand trajectory.

Figure 2: Red line is guide, blue dashed line (and arrow) is thewired delivery catheter.

Figure 3: Panel A shows a transgastric view of the wire deliverycatheter with panel B a zoomed view of the annulus andcatheter, showing an appropriate trajectory of the catheter.

Biplane imaging using the 30-60� view as theprimary view, will allow imaging of cathetersalong the posterior annulus.

Transgastric views place the posterior annulus inthe near field.

3. Visualize crossingwires acrosstricuspid valveannulus into theright atrium.

Echoa. Confirm wire crosses tricuspidvalve annulus into the rightatrium.

b. Assess annular tissue depth(ideal >2 mm).

c. Confirm position on theannulus at the septoposteriorcommissure.

Figure 4: The wire is visualized crossing the annular plane inpanelA,with themeasurementofdepthofannularwire crossing inpanel B.

Figure 5: Confirm the position of the wire using 3D imaging. Theblue dotted line represents the wire deliver catheter. The yellowarrow indicates wire crossing the annulus.

If the trajectory is not correct, the wire mayperforate the RA

Because of the significant variability of tricuspidvalve anatomy, the position within theannulus must be confirmed using 3D imaging.



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TABLE 3 Continued


4. Pledget deliverycatheter(following snareof the RA wire).

Echoa. Confirm pledget deliverycatheter crosses tricuspidvalve annulus. into the rightventricle

b. Confirm ventricular pledgetseating under annulus.

c. Confirm atrial pledget seatingonto the annulus.

Figure 6: Panel A, from transgastric view, shows the ventricularpledget (yellow arrow) folded onto the ventricular annulus.Panel B, from mid-esophageal view, shows the atrial pledget(red arrows) folded onto the atrial annulus.

Transgastric and esophageal views may be usefulthroughout the procedure.

5. Position secondwire delivery.

Echoa. Measure w2.4 to 2.8 cmdistance for second pledgetposition.

Figure 7: The distance between the first and second trans-annular wires is shown on a 3D en face view. Measurementsfrom the 3D view should be performed with caution becauseparallax may result in underestimation of the actual distance.Confirming using a multiplanar reconstruction is recommended.

A curved distance should be measured ifpossible.

6. Repeat steps 3and 4.

7. Cinch, plicate,and lock.

Echoa. Confirm 2 sutures are taught,not tangled.

b. Confirm cinching of the 2pledgets (using first pledgetas the fulcrum).

c. Position lock and cut sutures.

Figure 8: Panels A to C show the 2 pledgets being cinched withgradual narrowing of the distance between the pledgets. PanelD shows the lock with sutures cut.

2D ¼ 2-dimensional; 3D ¼ 3-dimensional; LA ¼ left atrial; TEE ¼ transesophageal echocardiography; TV ¼ tricuspid valve; other abbreviations as in Table 1.



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view, simultaneous multiplane imaging from thelateral TV annulus toward the aorta (a “sweep” acrossthe tricuspid annular plane) images the coaptationsite along the entire septal leaflet. Whereas each in-dividual patient should have the location of theregurgitation clearly identified to determine the best

strategy to reduce the regurgitation, Vismara et al.(17) developed an ex vivo model of functional TR andshowed that grasping the septal and anterior leafletsallowed for the best post-procedural outcome,ensuring a complete re-establishment ofphysiological-like hemodynamics. Although the most

TABLE 4 Intraprocedural Imaging Guidance With TEE and Fluoro for Transcatheter Tricuspid Repair With the Cardioband Tricuspid Valve

Reconstruction System


1. VisualizeGDC.

EchoImage introduction of the CDS into RA over TV annuluswith the GDC.

FluoroPositioning a coronary wire in the right coronary arteryis used as TV annular marker.

Assess correct position of the anteroseptal commissureand its distance to the right coronary artery.

Figure 1: CDS crossing into the RA and targeting theannulus in the region of first anchor delivery.

Figure 2: Fluoro projection shows the en face view(LAO/CAU) of the tricuspid valve and the rightcoronary artery, with the CDS delivering the firstanchor.

2D and 3D imaging essential.Mid-esophageal and deep-

esophageal viewshelpful.

RAO and LAO/CAU fluoroprojections essential toguide the CDS to theannulus.

2. Visualizeanchordeliverycatheter.

EchoConfirm position on the annulus above theanteroseptal commissure for first anchor deployment.

Figure 3: Position of the delivery catheter on theannulus in the region of the anteroseptal commissure.

Figure 4: Arrows indicate the target areas for theCardioband first and last anchor implantation. Checkthe anchor implantation is in the correct positionbefore releasing the anchor drive to ensure theCardioband is appropriately secured.

2D biplane imaging essentialfrom RA or RV approach.

3D view allows imaging ofcatheters along theposterior annulus.

Transgastric views place theposterior annulus in thenear field.



541

central (i.e., mid-leaflet) grasp is ideal, some in-vestigators have used a multidevice approach,grasping at the commissures to reduce the centralorifice before attempting mid-leaflet coaptation.

For controlled advancement of the clip deliverysystem and navigation of the clip delivery system tothe TV, a bicaval view aided by cross-plane imagingappears most helpful. Care should be taken that the

tip of the clip does not perforate the interatrialseptum while the clip is advanced to the TV. Once thetricuspid plane has been reached, but with the clipstill in the right atrium, an imaging plane which spansthe septal leaflet (from posterolateral to anteromedialadjacent to the aortic valve) is obtained using the 60�

to 80� commissural view (mid- to deep-esophagealwindow). Using this as the primary view,

TABLE 4 Continued


3. First anchordelivery.

Echoa. Confirm position on the annulus above the antero-septal commissure for first anchor deployment.

b. Assess anchor implantation with safe distance fromthe leaflet hinge point. Confirm delivery and checkanchor placement in tissue before releasing.

FluoroAssess delivery, implantation and release of anchorwith enough distance to right coronary artery.Confirm delivery and check anchor placement intissue before releasing.

Figure 5: Xplane and 3D echo views depict the samefirst anchor implantation position. Arrows show thetip of the CDS delivering the anchor in the TV annulus.

Figure 6: Fluoro projection showing a perpendicularview of the tricuspid valve plane, directed along thelong-axis of the right ventricle, during the first anchordelivery (wire in right coronary artery).

Live 3D zoom on the TVannulus and right atrium.

Echo imaging planes shouldbe adapted to theindividual patient.

LAO/CAU fluoro projectionto check the position andRAO to assess thetrajectory.

4. Repeatsteps forcompletebanddelivery.

Echoa. Confirm the several steps of anchor position andangle from first to last anchor implantation on theannulus until the coronary sinus. Confirm deliveryand check anchor placement in tissue prior toreleasing.

FluoroProgressive assessment of anchor delivery,implantation and release, with enough distance toRCA. Confirm delivery and check anchorplacement in tissue before releasing.

Navigating the tricuspid valve annulus for subsequentanchor implantation in the TV annulus, in a clockwisefashion.

The delivery system features multiple degrees of controlfor continuous navigation across the

TV annulus.In Figures 7 to 10 below, the red arrows indicate

progressive positioning of anchor delivery in aclockwise fashion on X-plane and corresponding 3Decho views.

Figure 7:

Figure 8:

Figure 9:

Transgastric views are idealfor posterior commissurebecause situated in thenear field.




542

TABLE 4 Continued


Figure 10:

Figure 11: Fluoro projections showing perpendicularviews of the tricuspid plane, used to assess thedevice’s trajectory and the co-axiality with thetricuspid annulus. This view is used to check properadvancement of the anchors.

Figure 12: Fluoro en face views used to navigatearound the tricuspid annulus for anchor deployment.

Figure 13: 3D imaging of the tricuspid valve annulusbefore Cardioband device (Panel A) and followingdevice implantation and cinching (Panel B).

CAU ¼ caudal; CDS ¼ Cardioband delivery system; fluoro ¼ fluoroscopy; GDC ¼ guide delivery catheter; LAO ¼ left anterior oblique; RAO ¼ right anterior oblique; RCA ¼ right coronary artery;other abbreviations as in Tables 1 and 3.


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simultaneous multiplane imaging from the lateral TVannulus toward the aorta (a sweep across thetricuspid annular plane) images the coaptation sitealong the entire septal leaflet, posterior-septal leafletcoaptation (near the lateral annulus), as well asanterior-septal coaptation (near the aorta). Simulta-neous multiplane imaging allows for adjustment ofthe trajectory of the device to the TV, localization ofthe target zone from TR color flow convergence, andpreliminary adjustment of clip rotation.

The next steps require a short-axis view of the TVfor final adjustment of clip rotation. Because of thefrequently insufficient temporal and spatial resolu-tion of 3D imaging of the thin TV leaflets, a trans-gastric 2D view often results in the best views of all

TV leaflets coaptation TV leaflets and is essential for acomprehensive understanding of the entire valvularapparatus (annulus, leaflets, and subvalvular tensorapparatus). It is also most valuable to localize gaps inleaflet coaptation and associated TR by correlatingflow convergence and vena contracta to TV anatomy.In this view, the clip can be advanced into the RVwith continuous monitoring of clip rotation; the clipadvancement should be visualized by simultaneousmultiplane imaging.

Grasping and securing leaflet insertion requires amid- to deep-esophageal commissural window withthe primary plane adjusted perpendicular to the cliparms showing the clip position along the commissure.The orthogonal simultaneous multiplane view aims to



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visualize both clip arms and leaflets concurrentlyduring grasping. Although this is often verydemanding, using the commissural view as the pri-mary view allows easy localization of the clip along theentire septal commissure, adjusting the secondaryplane slightly anterior (toward the aorta) to the clip foranteroseptal grasps, or slightly posterior (away fromthe aorta) for posteroseptal grasps. From this view, TRseverity and inflow gradients can also be re-evaluated.After clip placement, adequate leaflet tissue graspmust be confirmed before clip release. This usuallyrequires imaging from multiple views to ensure re-striction of the leaflet motion near the clip on 2D im-aging, an adequate tissue-bridge from 3D imaging, andreduction of TR by color Doppler. Three-dimensionalcolor Doppler planimetry of the vena contracta areamay be the best means of assessing reduction in TR,particularly in the setting of multiple residual jets.

FORMA SYSTEM

DEVICE OVERVIEW. The FORMA system (EdwardsLifesciences) was developed to address an importantunmet clinical need of reducing TR in high-risk,symptomatic patients. The spacer acts as a surfacefor valve leaflet coaptation, with the aim to reducethe regurgitant orifice, and initial experience hasshown the device reduces TR and is associated withsignificant functional improvement (8,18). The deviceis introduced typically from the left axillary vein viaopen cut-down procedure. The spacer is a foam-filledpolymer balloon that passively expands via holes inthe spacer shaft, and positioned across the tricuspidannulus over a rail. Two radiopaque markers help toinitially position the spacer using fluoroscopy. Thereare 3 spacer sizes currently available (12 mm, 15 mm,and 18 mm), with a length of 42 mm. The device isfixed at the distal end in the RV myocardium by a 6-pronged nitinol anchor that is designed to minimizeboth the risk of penetration of the epicardial surfaceand the prong exposure in the RV. The device is thenlocked to the rail and the distal end fixed in thesubclavian space.

PROCEDURAL IMAGING. Pre-procedural MSCT isused to evaluate vascular access anatomy and RVmorphology. Intraprocedural guidance relies onfluoroscopy and 2D, as well as 3D, TEE imaging(Table 6). After left axillary vein access, a 20-Fsheath (for the 12- to 15-mm spacers) or a 24-Fsheath (for the 18-mm spacer) is secured in placeand a right ventriculogram is performed to identifythe tricuspid annular plane and RV apex. An idealtarget location is identified at the RV wall perpen-dicular to the center of the annulus and at the septal

groove of the RV. A steerable delivery catheter isadvanced into the RV to deliver the rail system tothis ideal location. To ensure that the device doesnot become entangled with chordae, a balloon onthe tip of this delivery catheter is inflated beforecrossing the tricuspid annulus and advancing intothe RV. The anchor is then deployed into the RVmyocardium and adequate location and depth ofimplant confirmed by echocardiography; frequentlysimultaneous biplane imaging is helpful to imageanchor location along the RV free wall, and withinthe septal groove. A sweep of the rail in theanterior-posterior direction is performed to confirmthe absence of chordal or trabecular entanglementby pulling and pushing on the rail while imaging byechocardiography. The spacer is then tracked overthe rail to the TV plane and positioned by TEEguidance to optimize TR reduction. A limited rangeof positions (anterior and posterior) within theshort-axis plane of the annulus are possible giventhe access site from the superior vena cava. Theseptal-lateral position is typically dictated by thelocation of the anchor in the RV. The long-axis po-sition of the spacer should allow leaflet coaptationat the mid-spacer level. The device is then lockedproximally, and the excess rail length is coiled andplaced within a subcutaneous pocket. The entiredevice is fully retrievable during all stages of theprocedure, if needed, until sheath removal.

NAVIGATE TRANSCATHETER

TV REPLACEMENT

DEVICE OVERVIEW. The GATE System (NaviGateCardiac Structures, Inc., Lake Forest, California) iscomposed of an atrioventricular valved stent, a de-livery system, a compression loading system, and anintroducer sheath. The valve stent is nitinol alloywith a conical shape (Table 1) and is available in 4sizes (40- to 52-mm diameter) intended for nativetissue tricuspid annular diameters of 36 to 52 mm.Twelve RV tines grasp the tricuspid leaflets from theRV side. There are 12 right atrial (RA) wingletsperpendicular to the conical stent and covered by amicrofiber polyester cloth designed to provide a seal.The 3 leaflets and the skirt are made of treated equinepericardium. The delivery system consists of a tip-deflecting catheter designed to go through a 42-Fintroducer sheath. More than 16 GATE valves havebeen implanted in inoperable severe, symptomaticTR patients on a compassionate-use basis. Most ofthese have been implanted via the transatrial route.

PROCEDURAL IMAGING. Sizing of the device maybe performed using pre-procedural computed

TABLE 5 Summary of Intraprocedural TEE Imaging Recommendations for TV Edge-to-Edge Repair


1. Navigating CDSto TV.

TEEBicaval view with biplane imaging to navigate clipdelivery system within the right atrium to TV.

Secondary imaging plane should follow thetip of the clip delivery system toprevent tissue damage during clipdelivery system advancement.

2. Adjustment ofCDS trajectoryand clip rotation(in right atrium).

TEEMid-/deep-esophageal “commissural” view (60� to80�) with cross-plane imaging to optimize the clipdelivery system trajectory to the TV, and forpreliminary adjustment of clip position androtation at the target zone. Complete valveanalysis by sweeping through valve in secondaryplane.

3. Final positioningof clip at targetsite (in rightatrium).

TEETransgastric short axis view (10� to 40�) to visualizeall 3 leaflets and analyze valve anatomy; localizeleaflet coaptation gaps (at leaflet tips) andassociated regurgitation based on flowconvergence and vena contracta.

Multiple angulations of the imaging planemay be required if no single tangentialview can display the lines of coaptationin 1 plane.

4. CDSadvancementinto rightventricle.

TEETransgastric short axis view (10�to 40�) with cross-plane imaging. Facilitates navigation of clip byproviding simultaneous visualization of cliprotation, position in relation to TV leaflets/heightin right ventricle. Allows for final adjustment ofclip delivery system position and rotation.

FluoroMemorize clip rotation by adjusting angulation offluoroscopy.



545

tomography (CT) or 3D TEE. Given the limited num-ber of implantations, a precise sizing algorithm hasnot been developed; however, as little as 2% over-sizing may be sufficient. A planar cross-sectional areais measured in early systole and mid-diastole as pre-viously described (19). Although minimum andmaximum diameters are recorded, the sizing is typi-cally based on the area-derived average diameter. AnRCA angiography and placement of a coronaryguidewire is performed to help define the tricuspidannular plane fluoroscopically.

A minimally invasive right thoracotomy is per-formed in the predetermined location by CT and theatriotomy site and device trajectory perpendicular to

the annular plane is confirmed using TEE imaging(Table 7). After the RA puncture is performed, a wireand pigtail are positioned across the annulus and astiff wire is then introduced over the pigtail catheterand positioned in the RV apex. Wire positioning isconfirmed by both fluoroscopy and TEE. The intro-ducer sheath is then positioned with the tip 2 to 3 cminto the RA, and under TEE guidance the deliverysystem is inserted into the RA and centered in theannulus with shaft perpendicular to the annularplane.

Once the delivery system is centered and advancedacross the tricuspid annulus, the valve capsule isslowly withdrawn exposing the ventricular tines of

TABLE 5 Continued


5. Grasping view. TEEMid-/deep-esophageal “commissural” view (60� to80�) with cross-plane imaging. Adjust primaryplane perpendicular to clip arms to verify the clipposition along commissure, and to simultaneouslydisplay both arms and leaflets in the secondaryplane.

TTEIf adequate leaflet visualization cannot be obtained,a parasternal TV inflow view may be helpful forantero-septal grasping.

FluoroVerify clip rotation (and distance to further clips).

Small tidal ventilation volumes reduce out-of-plane movements of the clip duringthe grasping process.

5. Reevaluation ofTV repair.

TEEA mid-/deep-esophageal “commissural” view (60�

to 80�) with cross-plane imaging is also useful forreevaluation of TR grade and inflow gradient.

TTEFinal TTE for TR grading recommended as baselinefor follow-up.

TTE ¼ transthoracic echocardiogram; other abbreviations as in Tables 2 and 3.



546

the valve. The partially unsheathed valve is thenpositioned with the distal end just below the leaflettips, imaging leaflet engagement between the body ofthe valve and the tines. At this point, the atrial brim isstill restrained and some repositioning (either ven-tricular or atrial) is possible to ensure that the prox-imal edge of the device is within the atrium, butventricular tines remain below the annulus and leaf-lets before deploying the atrial end. Once the atrialbrim is deployed, the delivery system is carefullywithdrawn and the atriotomy and right thoracotomyclosed. Final imaging of the valve position, shape,and function is performed using both fluoroscopy andTEE.

ViV TRANSCATHETER TV REPLACEMENT

DEVICE OVERVIEW. Reoperative TV replacement isknown to be associated with very high operative risk(20,21). Following the demonstration of the feasibilityof ViV transcatheter aortic and pulmonic valvereplacement (22–25), ViV transcatheter tricuspidvalve replacement was investigated as a techniqueto avoid or delay the need for reoperation forbioprosthetic TV failure. The first reported trans-catheter TV replacement was performed with aballoon-expandable Sapien valve (Edwards Life-sciences) implanted through internal jugular venousaccess (26).

The largest series of ViV transcatheter TV replace-ment to date was published by McElhinney et al. (27)from the Valve-in-Valve International Database(VIVID) registry. This series included 152 patientswith a variety of types of failing bioprosthetic TVswho underwent ViV transcatheter TV replacement.The mode of failure was predominantly regurgitationin 24% of patients, stenosis in 29%, and mixed in47%. Transcatheter TV replacement was successful in99% of cases and was performed with the Melodyvalve in 62% and with the Sapien family of valves in38%. Transcatheter TV replacement led to significantimprovements in transvalvular gradients, tricuspidregurgitation grade, and symptomatology. During amedian follow-up of more than 13 months, 22 patientsdied and 10 TV re-interventions were performed.These results show the feasibility, clinical use,and midterm durability of ViV transcatheter TVreplacement.

The evaluation of patients for ViV transcatheter TVreplacement relies heavily on imaging, beginningwith transthoracic echocardiography and progressingto TEE or other imaging modalities when necessary.Echocardiography is the gold standard for assessingthe severity of bioprosthetic tricuspid stenosis andregurgitation. In patients with significant regurgita-tion, echocardiographic imaging must be of sufficientquality to rule out paravalvular regurgitation, whichmay require alternative treatment. Echocardiography

TABLE 6 Summary of Intraprocedural TTE and Fluoroscopic Imaging Recommendations for FORMA


1. Assess chordalentanglement withballoon passage.

Transgastric RV inflow/outflow view or mid-esophageal views can beused.

Figure 1: Panel A shows baseline transgastric imaging using the RVinflow/outflow view as the primary view. Panel B shows the ballooncatheter (blue) crossing the TV annulus to the RV to assess for chordalentanglement (Note yellow arrow indicates plane of the orthogonalview).

The balloon catheter may berepositioned if entanglement issuspected.

2. Guide catheter tip totarget.

3. Confirm catheter tip isup against myocardiumand in septal groove.

Transgastric views of the RVwith simultaneous biplaneimaging.

Figure 2: Panel A shows the fluoroscopic image of the catheter tip (blueline) at the target location (red arrow). Panel B shows the catheter (blueline/dot) on simultaneous multiplane imaging, against the RVmyocardium and in the septal groove (green line).

Biplane cursor should be at thecatheter tip to image the septalgroove in the orthogonal plane.

4. Confirm anchor is deepin myocardium beforesweep.

5. Move the rail across thetricuspid annulus(sweeping anterior toposterior) to excludeentanglement.

Mid-esophageal andtransgastric RV viewsshould be used to assessanchor position and depthof implant.

Figure 3: Panel A is an illustration of a deep anchor deployment, shownby echocardiography in Panel B; confirming from multiple views isrecommended. Panels C (fluoro) and D (echo) show the rail anterior inthe RV. Panels E (fluoro) and F (echo) show the rail moved freely intothe posterior RV.

Confirmation of anchor position anddepth into the RV myocardiumshould be performed from multipleviews (both mid-esophageal andtransgastric.

Both fluoro and echo should confirmfree movement of the rail.



547

may also be useful to exclude thrombus, vegetation,or other sequelae of endocarditis, which may alsohave an impact on therapeutic decisions. In patientswho are considered for a ViV procedure, it is criticallyimportant to establish the size of the existing pros-thesis to guide the choice of transcatheter valve.Although this information may be obtained in somecases from medical records or manufacturer records,

it should be verified by echocardiography or otherimaging studies.

PROCEDURAL IMAGING. Intraprocedure imaging forViV transcatheter TV replacement typically consistsof fluoroscopy and echocardiography (Table 8), whichmay be either transthoracic or transesophageal,depending on the case. A critically important step ofthe ViV procedure is the identification of the annular

TABLE 6 Continued


6. Guide adjustment ofspacer positioning (inanterior-posteriordirection) using colorDoppler.

7. Optimize reduction inTR.

Use 3D to visualize spacerplacement and makeadjustments as necessary.

Mid-esophageal andtransgastric RV viewsshould be used todetermine the numberand size of the residualjets.

Figure 4: 3D imaging of FORMA within the annular plane.

Figure 5: 2D color Doppler to assess TR.

The coaptation of the leaflets shouldoccur in the middle of the spacerdevice.

8. Assess residual TR. Use 3D color Doppler toplanimeter the venacontracta area.

Measure 2D vena contractawidths of the residual jets.

Figure 6: Panel A shows the 3D color Doppler assessment of the venacontracta areas (VCA) of the residual TR jets. Panel B shows the 2Dimaging of the vena contracta widths with simultaneous multipleimaging.

Proximal isovelocity surface areaassessment is not accurate forquantitation; however, a reductionin this parameter should be seen.

AO ¼ aorta; RVOT ¼ right ventricular outflow tract; other abbreviations as in Tables 1 to 4.



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plane and selection of an appropriate fluoroscopicprojection for transcatheter valve deployment. In themajority of cases, this can be achieved by aligning theradiopaque elements of the bioprosthetic valve,although RV angiography may be necessary in somecases. It is also important to observe the angle of theannular plane with respect to the planned accessroute, as this may have an impact on the ability to

achieve coaxial positioning of the transcathetervalve.

Once the annular plane is identified, the degen-erated bioprosthetic valve is crossed and a stiff wire ispositioned in the RV or the pulmonary artery. Thelocation of the distal wire should be selected so asto be as coaxial as possible to the prosthetic valveand to provide adequate support to advance the

TABLE 7 Summary of Intraprocedural TTE and Fluoroscopic Imaging Recommendations for Transcatheter Tricuspid Valve Replacement With the GATE Valve


1. Visualize the proposed right atrialpuncture site.

a. Image balloting of the roof of theright atriotomy site.

b. Measure the distance between theroof of the RA to the annulus.

Figure 1: Panel A is a gastroesophageal junction TEE view toimage the RA (yellow outline). Tricuspid leaflets (blue) definethe plane of the annulus (orange) with the probe “poking” anddeforming the atrial wall (red arrows). The simultaneousfluoroscopic view is shown in panel B. The Confida wire in theLV allows for pacing if needed.

Ideal site allows delivery of thedevice perpendicular to theannular plane.

Deep-esophageal andgastroesophageal junctionviews.

2. Visualize wire and pigtailcatheter delivery across thetricuspid annulus.

a. Confirm wire/catheter cross theannulus using fluoroscopy andecho.

b. Position stiff wire in the rightventricular apex.

Figure 2: Panel A (echo) and Panel B (fluoro) imaging of thewire (red arrows) across the annulus.

On fluoroscopy the RCA wiremarks the annulus.

Mid-esophageal and deep-esophageal views.

2D imaging gives highest framerates but 3D imaging maybe needed to locate wire.

3. Visualize introducer sheath andguide positioning of the deliverysystem across the annulus.

a. Confirm sheath is in the rightatrium using echo.

b. Guide delivery system crossingfrom atrium into ventricle byfluoroscopy and echo.

Figure 3: Panels A (mid-desophageal echo view) and B (fluoro)show confirmation of path of the delivery sheath.

Mid-esophageal and deep-esophageal views arehelpful.

4. Position the delivery system inthe right ventricle.

a. Center the delivery system withinthe annulus using echo.

Figure 4: 3D echo using the SAX view (green plane) to align theyellow and white orthogonal planes and center the device (bluecircle) in the middle of the annulus (orange arrows and orangedotted circle).

SAX views of the annulus usedto center the device(3D may be required).

5. Unsheathe distal (ventricular)portion of the valve.

a. Continuously image the exposureof the ventricular tines onfluoroscopy and echo.

b. Re-center device if necessary.c. Position the tines just below the

leaflet tips using echo.

Figure 5: Panels A (3D echo) and B (fluoroscopy) show theposition of the valve capsule (red arrows) as it is withdrawn tounsheathe the ventricular tines (blue arrows). Note on 3Dimaging aligning the 2 orthogonal planes (yellow and white)using the SAX view (green plane) allows for accuratepositioning.

SAX views of the annulus usedto center the device (3Dmay be required).



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TABLE 7 Continued


6. Unsheathe proximal (atrial) brimof the stented valve.

a. Ensure the proximal edge of thedevice is within the atrium. (Note:atrial brim still restrained.)

b. Re-check that the ventricular tinesare beneath the leaflets;repositioning is possible.

Figure 6: Panels A (echo) and B (fluoroscopy) show the positionof the constrained atrial brim (orange arrows) and theventricular tines (blue arrows) following deployment of theatrial brim.

7. Deploy the atrial brim andimmediately assess position andfunction of device.

a. After confirming position by echoand fluoro, the atrial brim isdeployed.

b. The device is not repositionable atthis point.

Figure 7: Panels A (echo) and B (fluoroscopy) show the positionof the exposed atrial brim (orange arrow) and the ventriculartines (blue arrow) following deployment of the atrial brim.

8. Withdraw the delivery system. a. Withdrawal of the system isdirected by echocardiography toensure TTVR leaflets are notcaught.

Figure 8: Panel A (echo) and Panel B (fluoroscopy) show saferemoval of the delivery system (orange arrow) across the newtranscatheter tricuspid valve replacement.

9. Assess valve position andfunction.

a. Image device from multiple viewsfor position within the annulus.

b. Color Doppler to assessparavalvular regurgitation.

c. CW Doppler for peak/meangradients.

Figure 9: Panel A (echo) shows a systolic frame with traceparavalvular tricuspid regurgitation and Panel B (fluoroscopy)right ventriculogram confirming trace tricuspid regurgitation.CW Doppler across the valve (Panel C) shows a peak and meangradient of <1 mm Hg.

Figure 10: 3D view of the transcatheter tricuspid valve (rightatrial side).

2D and 3D imaging useful.

LV ¼ left ventricular; SAX ¼ short axis; TTVR ¼ transcatheter tricuspid valve repair; other abbreviations as in Tables 1, 3, 4, and 5.



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TABLE 8 Summary of Intraprocedural TTE Imaging Recommendations for Transcatheter Tricuspid Valve-in-Valve Procedure


1. Verify Size ofdegeneratedbioprostheticvalve.

EchoIn addition to identifying and quantitatingstenosis and regurgitation, echo, particularly3D, may be useful to verify valve size andinternal dimension.

Cardiac CTAlthough less frequently required, gatedcardiac CT with or without contrast may alsobe useful to assist in verifying valve size.

Figure 1: Panel A shows 3D TEE images of a stenotic#33 Edwards Perimount valve. Panel B shows gatedcardiac CT imaging and sizing of the same valve.

Echo will be primary modality for pre-procedureimaging in most cases.

Cardiac CT may be useful in selected cases.

2. Visualizeannularplane ofdegeneratedbioprosthesis.

FluoroUse radiopaque elements of bioprosthesisframe to obtain appropriate coplanar view fordeployment.

EchoIdentify echo views to guide positioning ifnecessary and establish baseline imaging tofacilitate post-deployment assessment. Figure 2: Fluoro images of 2 different bioprosthesis

exemplify wide variation in radiopacity of differentmodels that can have an impact on the ease ofidentifying a coplanar view. Panel A shows a coplanarview of a #33 Edwards Perimount valve withextensive radiopaque elements in the basal ring andstent struts. Panel B shows a #33 St Jude Epic valvewith only a thin radiopaque marker at the base.

Fluoro will be primary modality to identify tocoplanar view and basal plane. RVangiography is rarely required.

2D or 3D echo imaging possible to facilitateprocedure.

3. Wirepositioning.

Fluoroa. The bioprosthetic valve is crossed, and ashaped, stiff wire is placed in the RV or PA.

Figure 3: Panel A shows wire with distal tip inpulmonary artery during balloon valvuloplasty.Panel B shows preferred wire position in the RV apex.

Wire position in the RV apex generally morecoaxial and favored when possible.

4. Transcatheterheart valvealignment.

FluoroUsing the middle marker (and outflow edge ofthe stent frame when the struts visible), theTHV is aligned with the bioprosthetic valve.

EchoMay assist in positioning THV in selected cases.

Figure 4: SAPIEN 3 positioning in THV in the above 2examples is shown. In Panel A, note difficulty inachieving coaxial position due to wire in pulmonaryartery. Adequate wire position and support in RV wasnot possible in this case due to small hyperdynamic RV.

THV positioning and deployment is primarilyguided by fluoroscopy.



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transcatheter valve delivery system. The trans-catheter valve is then advanced across the bio-prosthetic valve, positioned, and deployed. Althoughthis is typically performed under fluoroscopic

guidance, echocardiography may also be useful inmany cases. Rapid pacing is not always required, butcan be achieved with a coronary sinus lead or LV wirewhen desired. After deployment, echocardiography

TABLE 8 Continued


5. Transcatheterheart valvedeployment.

FluoroDeployment is guided by fluoroscopy.

Figure 5: SAPIEN 3 deployment in the above 2examples results in development of a “waist” (yellowarrows) in the THV, indicating adequate anchoring.

Appropriately sized THV should be deployed ordilated adequately to develop “waist.”

6. FinalAssessment ofViV TTVR.

EchoFinal intraprocedural assessment shouldinclude echocardiography.

Figure 6: TEE imaging demonstrating adequateposition, deployment, and anchoring in Panels A andB. Transvalvular gradient and residual tricuspidregurgitation should also be evaluated as shown inPanels C and D.

TTE or TEE should focus on evaluation of THVposition, anchoring, transvalvular gradient,and residual tricuspid regurgitation(typically paravalvular).

CT ¼ computer tomography; PA ¼ pulmonary artery; THV ¼ transcatheter heart valve; TTVR ¼ transcatheter tricuspid valve replacement; ViV ¼ valve-in-valve; other abbreviations as in Tables 3 and 4.



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and/or right ventriculography should be performed toverify adequate positioning and to evaluate trans-valvular gradients and regurgitation.

CONCLUSIONS

Multiple transcatheter devices for the treatment offunction TR are currently under investigation. Thisreview describes the intraprocedural imaging re-quirements for a representative sample of these

devices to exemplify some of the imaging successesand challenges in this field. As new devices and newimaging tools are developed, intraprocedural imagingprotocols will continue to evolve.

ADDRESS FOR CORRESPONDENCE: Dr. Rebecca T.Hahn, Columbia University Medical Center, NewYork-Presbyterian Hospital, 177 Fort WashingtonAvenue, New York, New York 10032. E-mail: [email protected].

RE F E RENCE S

1. Nath J, Foster E, Heidenreich PA. Impact oftricuspid regurgitation on long-term survival. J AmColl Cardiol 2004;43:405–9.

2. Lee JW, Song JM, Park JP, Kang DH, Song JK.Long-term prognosis of isolated significanttricuspid regurgitation. Circ J 2010;74:375–80.

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mailto:[email protected]

mailto:[email protected]

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KEY WORDS transcatheter, tricuspidregurgitation, tricuspid valve










































































intraprocedural imaging of transcatheter tricuspid valve...

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