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STATE-OF-THE-ART PAPER Standardized Imaging for Aortic Annular Sizing Implications for Transcatheter Valve Selection Albert M. Kasel, MD,* Salvatore Cassese, MD,* Sabine Bleiziffer, MD,† Makoto Amaki, MD, PHD,‡ Rebecca T. Hahn, MD,§ Adnan Kastrati, MD,* Partho P. Sengupta, MD‡ Munich, Germany; and New York, New York The safety and efficacy of transcatheter aortic valve replacement procedures are directly related to proper imaging. This report revisits the existing noninvasive and invasive approaches that have concurrently evolved to meet the demands for optimal selection and guidance of patients undergo- ing transcatheter aortic valve replacement. The authors summarize the published evidence and discuss the strengths and pitfalls of echocardiographic, computed tomographic, and calibrated aortic balloon valvuloplasty techniques in sizing the aortic valve annulus. Specific proposals for 3-dimensional tomographic reconstructions of complex 3-dimensional aortic root anatomy are pro- vided for reducing intermodality variability in annular sizing. Finally, on the basis of the sizing approaches discussed in this review, the authors provide practical recommendations for balloon- expandable and self-expandable prostheses selection. Strategic use of echocardiographic, multislice computed tomographic, and angiographic data may provide complementary information for deter- mining the anatomical suitability, efficacy, and safety of the procedure. (J Am Coll Cardiol Img 2013; 6:249 – 62) © 2013 by the American College of Cardiology Foundation T ranscatheter aortic valve replacement (TAVR) provides an alternative treat- ment option for inoperable and high– surgical risk patients with symptomatic severe aortic stenosis (1–4). On the basis of evidence from a recent randomized trial (5,6), balloon-expandable prostheses (Edwards SAPIEN; Edwards Lifesciences, Irvine, Cali- fornia) received U.S. Food and Drug Admin- istration approval for the U.S. market (7). Similarly, there is extensive evidence for self- expandable prostheses (CoreValve ReValving System; Medtronic, Inc., Minneapolis Minne- sota), and randomized trials are expected to be completed in the next few years (3,4,8,9). The safety and efficacy of the TAVR proce- dure are directly related to proper imaging, which is based on patient selection and proce- dural guidance. However, as opposed to surgi- cal aortic valve replacement, in which surgeons can directly observe the adaptation of the prosthesis to the aortic root while suturing, From the *Clinic for Cardiology and Cardiovascular Diseases, Deutsches Herzzentrum, Technische Universität, Munich, Germany; †Clinic for Cardiovascular Surgery, Deutsches Herzzentrum, Technische Universität, Munich, Germany; ‡The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai School of Medicine, New York, New York; and §Columbia University Medical Center/New York Presbyterian Hospital, New York, New York. Dr. Kasel is a proctor for Edwards Lifesciences and Medtronic, Inc. Dr. Bleiziffer is a proctor for Medtronic and JenaValve, and is a steering committee member of the Engager Pivotal Study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received November 26, 2012; revised manuscript received December 20, 2012, accepted December 21, 2012. JACC: CARDIOVASCULAR IMAGING VOL. 6, NO. 2, 2013 © 2013 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 1936-878X/$36.00 PUBLISHED BY ELSEVIER INC. http://dx.doi.org/10.1016/j.jcmg.2012.12.005
Transcript
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Standardized Imaging for Aortic Annular SizingImplications for Transcatheter Valve Selection

Albert M. Kasel, MD,* Salvatore Cassese, MD,* Sabine Bleiziffer, MD,†Makoto Amaki, MD, PHD,‡ Rebecca T. Hahn, MD,§ Adnan Kastrati, MD,*Partho P. Sengupta, MD‡

Munich, Germany; and New York, New York

The safety and efficacy of transcatheter aortic valve replacement procedures are directly related to

proper imaging. This report revisits the existing noninvasive and invasive approaches that have

concurrently evolved to meet the demands for optimal selection and guidance of patients undergo-

ing transcatheter aortic valve replacement. The authors summarize the published evidence and

discuss the strengths and pitfalls of echocardiographic, computed tomographic, and calibrated aortic

balloon valvuloplasty techniques in sizing the aortic valve annulus. Specific proposals for

3-dimensional tomographic reconstructions of complex 3-dimensional aortic root anatomy are pro-

vided for reducing intermodality variability in annular sizing. Finally, on the basis of the sizing

approaches discussed in this review, the authors provide practical recommendations for balloon-

expandable and self-expandable prostheses selection. Strategic use of echocardiographic, multislice

computed tomographic, and angiographic data may provide complementary information for deter-

mining the anatomical suitability, efficacy, and safety of the procedure. (J Am Coll Cardiol Img 2013;

6:249 – 62) © 2013 by the American College of Cardiology Foundation

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Transcatheter aortic valve replacement

(TAVR) provides an alternative treat-ment option for inoperable and high–surgical risk patients with symptomatic

evere aortic stenosis (1–4). On the basis ofvidence from a recent randomized trial (5,6),alloon-expandable prostheses (EdwardsAPIEN; Edwards Lifesciences, Irvine, Cali-ornia) received U.S. Food and Drug Admin-stration approval for the U.S. market (7).imilarly, there is extensive evidence for self-

From the *Clinic for Cardiology and Cardiovascular Diseases, DeutGermany; †Clinic for Cardiovascular Surgery, Deutsches HerzzentrZena and Michael A. Wiener Cardiovascular Institute, Mount Si§Columbia University Medical Center/New York Presbyterian HosEdwards Lifesciences and Medtronic, Inc. Dr. Bleiziffer is a procommittee member of the Engager Pivotal Study. All other authorsto the contents of this paper to disclose.

Manuscript received November 26, 2012; revised manuscript received D

xpandable prostheses (CoreValve ReValvingystem; Medtronic, Inc., Minneapolis Minne-ota), and randomized trials are expected to beompleted in the next few years (3,4,8,9).

The safety and efficacy of the TAVR proce-ure are directly related to proper imaging,hich is based on patient selection and proce-ural guidance. However, as opposed to surgi-al aortic valve replacement, in which surgeonsan directly observe the adaptation of therosthesis to the aortic root while suturing,

s Herzzentrum, Technische Universität, Munich,Technische Universität, Munich, Germany; ‡TheSchool of Medicine, New York, New York; andl, New York, New York. Dr. Kasel is a proctor forfor Medtronic and JenaValve, and is a steering

e reported that they have no relationships relevant

ecember 20, 2012, accepted December 21, 2012.

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poetGomde

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TAVR does not permit the prediction of interac-tion between the sutureless transcatheter prosthesesand surrounding structures before implantation.Therefore, an in-depth understanding of aorticroot anatomy has become pivotal over the pastfew years (10). Thus, imaging techniques havegarnered growing attention because they allowmore precise measurements of the annulus andaortic root for proper definition of the spatialorientation of the aortic valve complex. This isimportant because these features guide the eligi-bility of patients for TAVR and allow adequatedevice sizing (11).

Herein, we propose 3 techniques for sizing anaortic valve annulus before TAVR and discusstheir implications for the currently available se-lection of prostheses. Although the exact utilityand success of these approaches await prospectiveconfirmation, the step-by-step approaches high-lighted here should serve primarily as a guide forthe methodological approaches available for siz-ing the aortic valve annulus for patients under-

going TAVR.

Studying the Aortic Valve Anatomyto Match it with an AdequatelySized Prosthesis

In TAVR, “sizing” can be defined as thechoice of prosthesis within a range ofavailable sizes to ensure that it is bestaccommodated into the native aortic

root. This sizing is dependent on the observationof anatomy-device interaction and represents oneof the most important predictors of a successfulprocedure (3,4,12).

During TAVR, the size of the aortic valveannulus is used as a standard measurement forquantitative assessment of the site of implanta-tion. By definition, an annulus should be in theform of a ring. However, previous reports havequestioned the concept of a distinct anatomicaortic annulus given the structure of the aorticroot and semilunar-shaped cusps (10). Second,the close anatomical continuity of the left ven-tricular outflow tract into the ascending aortaprecludes clear identification of the individualanatomic components (13).

Arguably, the diameter of the aortic root variesconsiderably, and it depends primarily on the direc-tion in which the diameter is measured. Piazza et al.(10) reported that the aortic root has a 3-

dimensional structure in which 3 main circular p

rings, planes, and a crownlike ring can be recog-nized, and all of these originate from the aorticvalve leaflets, which are attached throughout thelength of the aortic root. The aortic valve annulustypically represents the tightest part of the aorticroot and is defined as a virtual ring with 3anatomical anchor points at the base of each ofthe attachments of the aortic leaflets (Fig. 1). Thesize of a transcatheter valve prosthesis tradition-ally relied on the dimensions of the aortic annulusduring systole, with the native leaflets and theirhinge points providing the first resistance andanchoring force to the prosthesis.

The ability to provide the correct measurementof the aortic valve annulus is essential to avoidundersizing and oversizing of transcatheter heartvalves. Undersizing of the aortic valve annulus couldlead to the selection and deployment of a smallerprosthesis, which could result in paravalvular regur-gitation (14) and valve embolization (15). In con-trast, oversizing can lead to underexpansion ofthe prosthesis, with possible reduced valve dura-bility, conduction disturbances leading to perma-nent pacemaker insertion, or annular rupture(16). In general, transcatheter prostheses aredesigned to be deployed in annuli that are slightlysmaller than the prostheses. This “controlled”oversizing is essential for anchoring a suturelessprosthesis (11).

Because of the particular characteristics oftranscatheter prostheses, a complete assessmentof the anatomy of the aortic valve complex isrequired during pre-procedural decision making.To date, 3 imaging techniques have been pre-dominantly used to perform sizing before TAVR:echocardiography, multidetector computed to-mography (MDCT) imaging, and intraoperativeballoon sizing.

Imaging Tools for Aortic Annular Sizing

Transesophageal echocardiography (TEE). In clinicalractice, patient eligibility and the determinationf prosthesis size are currently based largely onchocardiography, which is an essential imagingool for all patients undergoing TAVR (17,18).iven the increased understanding of the anat-

my of the aortic valve, a single-dimensionaleasurement is no longer accepted as the sole

eterminant of transcatheter valve sizing. How-ver, 2-dimensional transthoracic echocardiogra-

A B B R E V I A T I O N S

A N D A C R O N YM S

MDCT � multidetector

computed tomography

TAVR � transcatheter aortic

valve replacement

TEE � transesophageal

hy is the first step to assess aortic valve stenosis

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severity and initial sizing of the aortic valveannulus. Three reference planes intersecting at90° to one another are used for quantitativeanalysis. The plane of the valve is referred to asthe transverse plane, and the planes orthogonal tothe transverse plane define the sagittal (anterior-to-posterior) and coronal (left-to-right) referenceplanes. Although direct comparison of transtho-racic echocardiography and TEE has suggestedthat systolic sagittal plane measurements on TEEare approximately 1 mm larger than on transtho-racic echocardiography, this may result fromimage quality rather than from inherent differ-ences in techniques (19,20). With either modal-ity, in the long-axis view, the annular dimensionmeasured on the sagittal plane is the shorter one,while that measured on the coronal plane is thelonger one. Thus, it is of a paramount importanceto ascertain the cross-sectional anatomy of theannulus, which can be performed in the short-axis view or more accurately using 3-dimensionalimaging.

The guidelines of the American Society ofEchocardiography (21) and the consensus docu-ment on TAVR (11) recommend TEE beforeTAVR if there are issues regarding aortic rootanatomy, aortic valve annular diameter, or thenumber of cusps. With TEE, the size of the

Figure 1. Normal Anatomy of the Aortic Annulus

The aortic annulus accounts for the tightest part of the aortic rootanchor points at the nadir (green points) of each of the attachmencoronary cusp; RCC � right coronary cusp.

aortic valve annulus at the level of basal attach-

ment or hinge points of the aortic valve cuspsdictates the size of the prosthesis. Annular sizemeasurement should be performed using theenlarged view of the midesophageal long axis(approximately 110° to 140°, referred to as the“3-chamber view”) during the early systolic phaseof the cardiac cycle. In this projection, the leftventricular chamber, outflow tract, and ascendingaorta should be aligned along their long axes toensure that the sagittal plane bisects the maximaldiameter of the annulus. Oblique measurementsmay lead to overestimation of the annular dimen-sions (Fig. 2A). Once the aforementioned ana-tomic structures are aligned, the aortic valveannulus can be measured following the trailingedge–to–leading edge convention. The measure-ment should be performed from the edge of sinusto the hinge point of the right coronary cuspperpendicular to the long axis of the aorta (Fig. 2B).Because in this long-axis view, the plane passesposteriorly between the commissure situated withinleft and noncoronary cusps, a distinct anatomiclandmark (such as the hinge point of a cusp) cannotbe clearly delineated. Proper attention is required toavoid measurement of bulky commissural calciumthat is often present within the sinus of Valsalva,leading to overestimation of the actual annular size.The measurement must exclude ectopic calcifica-

and is defined as a virtual ring (green line) with 3 anatomicalf the 3 aortic leaflets (B). LCC � left coronary cusp; NCC � non-

(A)ts o

tions, with the points measured outside the calcifi-

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moving frames in cine loop back and forth to rule out artifacts (C).

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cations. In some cases, real-time imaging may helpdistinguish side-lobe and reverberation artifactsfrom real structures (Fig. 2C). Although measure-ments from 2 to 5 beats can be averaged, it isimportant to remember that cyclic variation inthe location of the sagittal plane occurs withrespirations or within the RR cycle. An enlargedshort-axis view on TEE illustrates the aortic valveopening and location and extent of calcifications.The new generation of ultrasound scanners offersmultiplanar imaging with simultaneous acquisi-tion of short-axis and long-axis planes, a featurethat could be helpful for finding a plane thatbisects the annulus, especially when patients areexamined with limited echocardiographic windows.Two-dimensional TEE possesses the inaccuracy ob-served in monoplanar displays. Furthermore,2-dimensional TEE has some specific drawbacks dueto the unique measurements required for TAVR.Although the operator can obtain a symmetric visu-alization of the cusps, their measurement could provechallenging (20,22,23). Although 3-dimensionalTEE lacks adequate standardization and is not yetroutinely available, there is some evidence suggestingthat this method is a valid alternative for more precisepre-procedural measurements in the setting ofTAVR, potentially reducing the possibility of sizingerrors (24–27).

We propose a 3-step approach, referred to as the“turnaround rule,” to easily define aortic valve an-nular size (Fig. 3). Two-dimensional TEE is per-formed to obtain a short-axis view of the aorticvalve. Three-dimensional TEE is then performedover zoom mode to acquire loops with the narrow-est possible depth, with adjustment of lateral widthand elevation width for obtaining a volume contain-ing the whole aortic root, the left ventricular out-flow tract, and part of the ascending aorta; volumerates of at least 10/s will allow an accurate assess-ment of early systole. The loop is then assessed witha 3-dimensional commercially available softwarepackage with standard short-axis views of the aorticvalve (Fig. 4) in mid systole used as a referenceframe. First, the transverse and sagittal and cor-onal orthogonal planes are oriented along theaortic root such that all planes intersect at thecenter of the opened valve, with the sagittal andcoronal planes aligned parallel to the long axis ofthe ascending aorta. Second, the orthogonalplanes are rotated to identify the most caudalattachments of the aortic valve leaflets (hinge

Figure 2. Aortic Annular View With TransesophagealEchocardiography

Midesophageal long-axis zoomed-up view (“3-chamber view”)during the early systolic phase of the cardiac cycle (A). The leftventricular chamber (LV), the outflow tract (OT), the aortic valve(AV), and the ascending aorta (AA) are aligned. An orthogonalplane is considered as a reference (B, dotted yellow line). The 4edges of the aortic sinus (yellow points) are the landmarks: thesinotubular junction defines the upper reference plane, and theinsertion point of the aortic valve leaflets on the outflow tractdefines the lower reference plane. The aortic valve annulus ismeasured as the distance between the hinge point of the rightcusp and the edge of the sinus at the side of the commissuresbetween the left and noncoronary cusps, including calcifications(red line with arrowheads). It is useful to select the landmarks by

points). It is important to remember that the

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hinge-point plane refers to the virtual annularplane. The transverse plane is repositioned fromthe aorta toward the ventricle until it reaches thelevel of the hinge points. In the setting of severely

Figure 3. Alignment of Aortic Root Planes With 3-Dimensional T

The colors used through selected images (lines and planes) reflectleft ventricular outflow tract (LVOT) is chosen as a reference with thdots). The planes orthogonal to the transverse plane are rotated (2sinuses. The transverse plane is moved toward the left ventricular olet insertion. The orthogonal plane is further rotated (4) to ensure tnoncoronary cusp (NCC). The longest (D1) and the shortest (D2) diaAbbreviations as in Figure 1.

Figure 4. Artifacts With Computed Tomographic Angiographic S

Image distortion caused by motion artifacts is depicted (A, B, red arrow

calcified and immobile cusps, bulky calcificationsof the cusps may extend into the plane of theannulus in systole, making an accurate measure-ment more difficult. In addition, acoustic artifacts

sesophageal Echocardiography

3-dimensional schematic reconstructions. The center axis of theansverse plane (1) placed parallel to the sinotubular junction (reddelineating the hinge point of the left and right coronary

ow (3) to arrive at the level of the hinge points of the aortic leaf-the transverse plane also crosses through the hinge point of theers, the circumference, and the area of the annulus are measured.

s

ran

thee tr) forutflhatmet

can

s).

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such as side lobes or acoustic shadowing mayreduce accuracy. Finally, the orthogonal planesare repeatedly rotated (the turnaround rule) toensure that the hinge points of the aortic valveleaflets are transected by the transverse plane.The annulus is typically oval in its appearance,with the minimal dimension in the sagittal planeand the maximal dimension in the coronal plane.These measurements, as well as the perimeter andannular area, can then be measured on the trans-verse plane. A mean annular diameter (the mean

Figure 5. Alignment of Aortic Root Planes With Multislice Comp

The colors used through selected computed tomography images (ltions (top). The center axis of the left ventricular outflow tract anda 90° angle. The crosshair are moved in the middle of the aortic(A, B, bottom, orange/blue lines). The transverse plane is aligned afrom the aorta towards the ventricle (A, B, bottom, white arrows)points) come into view (D, transverse plane). The transverse plane

to the virtual annulus plane in which no valve structure is visible. A �

of the minimal and maximal diameters) or a meanannular diameter (from the perimeter or area) canbe calculated.MDCT imaging. Over the past few years, MDCTimaging has become an essential tool for provid-ing detailed and reliable description of the com-plex 3-dimensional aortic root anatomy in pa-tients undergoing TAVR. Indeed, tomographicimages of the aortic annulus, commissures, andsinuses of Valsalva, where the coronary arteriesoriginate, provide an in-depth understanding of

d Tomography

and contours) reflect the 3-dimensional schematic reconstruc-nding aorta is chosen as a reference with the 3 planes locked int to align the longitudinal axis in coronal and sagittal planese level of the valve (C, valve plane), dragging this plane downl the most caudal attachment of the aortic valve leaflets (hingee basis for the alignment of the hinge point plane which refers

ute

inesasceroot thuntiis th

anterior; L � left; P � posterior; R � right.

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the framework within which the aortic valveleaflets are suspended (20,28 –31). These pre-operative assessments are required because of thelack of direct valve visualization when the proce-dure is performed. Consensus regarding TAVRrecommends the use of MDCT systems with atleast 64 detectors and spatial resolution of 0.5 to0.6 mm (11).

Suggested scanning protocols for annular siz-ing during TAVR include electrocardiographi-cally synchronized (gated) imaging of the aorticroot, which is important to avoid motion-inducedartifacts (Figs. 4A and 4B). Image reconstructioncan be performed in the desired phase of thecardiac cycle, and in contrast to transesophagealechocardiographic measurements, MDCT imag-ing does not report any significant differenceswith respect to diameters, which are acquiredduring the systolic or diastolic phase (28). Werecommend using the phase of the cardiac cyclewith the best image quality. Reconstruction ofthe annulus should be performed orthogonally inrelation to the central axis of the left ventricularoutflow tract; this permits correct understandingof minimal and maximal diameter, circumfer-

Figure 6. Spatial Reconstruction of the Aortic Annulus With the

Scheme (A) and computed tomographic images (B to D): the transtime the nadirs of the aortic valve leaflets with the transverse plane

sured in the longitudinal axis at a right angle to the hinge point plane

ence, and area, while emphasizing the presence ofa noncircular aortic valve annulus (reported in upto 40% of patients who may need TAVR)(20,24,30,32,33).

The turnaround rule is useful to define theaortic valve annular size with the help of simplemultiplanar rendering software (with the 3 planeslocked at a 90° angle), and it is integrated inalmost all of the workstations used for cardiacimaging. First, the crosshairs should be moved tothe middle of the aortic root, and the longitudinalaxis in the coronal and sagittal plane should bealigned (double oblique planes) (Figs. 5A and5B). Second, the transverse plane should bealigned at the level of the valve (valve plane) bydragging this plane down from the aorta towardthe ventricle until the most caudal attachments ofthe aortic valve leaflets (hinge points) come intoview (Figs. 5C and 5D). Finally, the transverseplane should be rotated around its own axis toalign the longitudinal planes (coronal oblique andsagittal oblique planes) to ensure that the hingepoints of the aortic valve leaflets individuallytouch the transverse plane (Figs. 6A to 6D).Ideally, when the orientation of the transverse

rnaround Rule”

e plane is turned clockwise around its own axis to align one at a3 steps (1–3). The distances to the coronary ostia can be mea-

“Tu

versin

(B, C, red arrows). Abbreviations as in Figure 1.

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Toaamto

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plane is correct, all 3 aortic valve leaflets appear ordisappear simultaneously by moving this plane ina caudal or cranial fashion. If the planes need tobe realigned to minutely adjust the transversalplane, it should be ensured that all 3 cusps touchthe plane again while the transverse plane isturned around 1 more time. Once the hinge pointplane is aligned, the measurement can be per-formed in this plane or 1 section below (in theupper outflow tract) because of the excellentspatial resolution associated with previous gener-ation of MDCT systems. However, it must beremembered that in the current setting of clinicalpractice, although imaging refinements are avail-able, the proper identification and alignment ofthe plane on which the virtual ring is situatedmight be difficult because of heavy calcificationsor extremely oval annuli. Both of these issuescould lead to distortion of the aortic root. Inthese cases, patients would benefit most frommultimodality imaging (20,22,34,35).

Figure 7. Aortic Annular Measurements at Hinge-Point Plane

(A) Minimal and (B) maximal dimensions are drawn manually through t

Once alignment has been performed, it is possi-ble to trace a polygonal line that circumscribes theaortic valve annulus (visible at the transverse planelevel) to determine its area and perimeter. Minimaland maximal dimensions can be manually deter-mined through the center point of this annulus,with the mean diameter being the mean of these 2measures or calculated using the area or circumfer-ence (Fig. 7). Bioprostheses are supposed to havea circular cross-section. In this respect, the diam-eter derived from this ideal circumference iscalculated as: (perimeter of the traced poly-gon)/�, while the area is calculated as: [2 �✓(area of traced polygon in mm2/�)] (36,37).

he distance of the valve plane from the coronarystia should be measured in the longitudinal axist right angle to the hinge point plane (Figs. 6Bnd 6C). The importance of MDCT measure-ents performed at the transverse plane level and

he potential drawbacks associated with errone-us measures are described in Figure 8.

he center point of the aortic valve annulus.

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he h

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Several lines of evidence have demonstratedthat MDCT measurements of the virtual basalring (mean diameter, circumference, and area) aremore reproducible than echocardiography(20,29,33). The use of MDCT measurementscould result in changes in strategy in a greaternumber of patients compared with TEE (20)because of its close correlation with direct surgi-cal measures (38,39) and a high degree of repro-ducibility (37).

Annular sizing and the assessment of aortic rootorientation would allow the prediction of the aorticroot angle before the procedure (40,41). This mightpotentially decrease the number of aortograms re-quired during the procedure and therefore reducethe procedure time and need for contrast, therebyimproving the precision of bioprostheses deploy-ment (40).Calibrated balloon aortic valvuloplasty. Althoughthere have been continual advances in imagingtechniques, the characteristics of degenerativeaortic valve stenosis can lead to very challengingscenarios in the setting of TAVR. Furthermore,because of conflicting measurements obtainedwith multimodal imaging, annular sizing using 2different prosthesis sizes, asymmetric calcifica-tions, or eccentric leaflets, there can be uncertain-ties regarding the selection of an optimal pros-

Figure 8. Errors During Measurements at the Level of the Aorti

False measurements, as well as correct aortic annular definition at t

thesis for TAVR (20,42). In those cases, balloon

aortic valvuloplasty (43) after proper calibration(44 – 46) could be used as a tool for direct annularsizing and correct prosthesis selection in the

ot

inge-point plane, are illustrated.

Figure 9. Aortic Annular Sizing Through Balloon Valvuloplastyand Simultaneous Aortography

Indirect signs of proper measurements: the lack of movement ofthe balloon within the aortic valve (yellow line with arrow-head), the possible waist of the balloon at the level of theannulus (red arrows), the residual contrast medium regurgita-tion between the maximally inflated balloon and the hingepoints of the valve (blue arrow), and the calcified leaflets

c Ro

splayed against coronary ostia (green arrow).

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Figure 10. Recommendations for Balloon-Expandable and Self-Expandable Prosthesis Selection

Commercially available prostheses are presented (Edwards SAPIEN [A] and SAPIEN XT [B].

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tion

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catheterization laboratory. For instance, previousreports have suggested that balloon aortic valvu-loplasty could directly influence the change inthe size of the prosthesis in up to 25% ofpatients (45).

As illustrated in Figure 9, during rapid pacing,balloon valvuloplasty performed simultaneouslywith contrast injection at the level of the ascend-

Figure 10. Continued

Edwards Lifesciences; CoreValve ReValving System [C], Medtronic, InSAPIEN and SAPIEN XT prostheses, the 23-mm and 25-mm balloonsascending aorta; BAV � balloon aortic valvuloplasty; CoV � CoreVaEdwards SAPIENT XT; TEE � transesophageal echocardiography. aRathe authors’ personal experience. cComputed tomographic confirma

Figure 11. Annular Calcifications and Bioprosthesis Oversizing

Annulus without calcification (A), annulus with moderate calcifications

ing aorta can provide an indirect confirmation ofadequate sizing through several signs: first, thelack of balloon movement within the aortic valve;second, the waist of the balloon present at thelevel of annulus; and third, the absence of regur-gitation of the residual contrast medium betweenthe maximally inflated balloon and hinge pointsof the valve. Moreover, during balloon valvulo-

with ideal measurements and requested oversizing. For Edwardsvided from the manufacturer can be used for sizing. AsAo �

CT � computed tomography; MD � mean diameter; SXT �

provided by the manufacturer. bRange suggested according tois required.

c.)prolve;nge

(B), and annulus with severe or diffuse calcifications (C).

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plasty, operators can reliably predict the finalposition of the splayed calcified leaflets to excludethe potential risk for coronary ostia occlusionafter TAVR.

Prosthesis Selection after Aortic Annular Sizing

Once definitive measurements have been made,the prosthesis with the correct size that ade-quately fits the annular diameter should be se-lected on the basis of charts provided by manu-facturers and one’s own experience (Figs. 10A to10C). Because balloon-expandable valves are de-signed to reach a definite diameter and form afterdeployment, they can change the shape of theannulus remarkably. In contrast, self-expandableprostheses are more prone to accommodate nativeanatomies. Thus, for TAVR, especially withballoon-expandable prostheses, procedural suc-cess and inherent risks are highly dependent onproper annular sizing. In this regard, it must beacknowledged that balloon-expandable trans-catheter prostheses (Edwards SAPIEN, availableonly in the United States, and SAPIEN XT,available only in Europe) are available in 3-mmstep sizes (namely, 23 and 26 mm for the Ed-wards SAPIEN valve and 23, 26, and 29 mm forthe SAPIEN XT valve), while self-expandabletranscatheter prostheses are available in 3-mmstep sizes up to 29 mm, with a newly available2-mm step size of 31 mm. This aspect couldrepresent a problem when measurements of theaortic annulus are in the overlapping area be-tween 2 different prosthesis sizes. In such cases,attention must be paid to the extent of calcifica-tion of the leaflets to avoid the risk for aortic rootrupture. In cases of annuli without calcification

plantation 10-year anniversary: re- aortic-valve repla

mm bigger than the annular size. However, incases of moderate calcification (Fig. 11B), thevalve size should be �0.5 mm bigger than annu-lar size, and for severe or diffuse calcification(Fig. 11C), the chosen valve size could be nearlyequal to the annular size. With the currentlyavailable bioprostheses, up to 97% of patients areanatomically suitable for TAVR, suggesting thata wide array of bioprostheses will permit themanagement of patients with severe aortic steno-sis who are at high or prohibitive risk for surgery(47– 49).

Conclusions

As technology and imaging rapidly evolve, refine-ments to TAVR procedures are expected todiminish the uncertainty that still surrounds theirwidespread application, potentially leading to anincrease in frequency resembling that seen withpercutaneous coronary intervention over the past2 decades. As the procedures become simpler andsafer, it is more likely that they will be performedmore often. Therefore, clear and easily available3-dimensional imaging and device ameliorations,in addition to increasing the experience of oper-ators, will play a pivotal role for TAVR, especiallyin the setting of patient eligibility and prosthesisselection. The overall aim is to avoid the seriousconsequences due to undersizing or oversizing inthis clinical scenario.

Reprint requests and correspondence: Dr. Albert M. Kasel,eutsches Herzzentrum, Technische Universität, Laza-

ettstrasse 36, Munich, Germany. E-mail: [email protected]. OR Dr. Partho P. Sengupta, Mount Sinaichool of Medicine, One Gustave L. Levy Place, Box030, New York, New York 10029. E-mail: partho.

(Fig. 11A), the valve size should be at least �1 [email protected].

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Key Words: aortic stenosis ycomputed tomography yechocardiography y patientselection y transcatheter aortic

alve implantation.

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