transvascular aortic valve replacement planning: … are manufacturer s guidelines for sizing for...

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DisclosuresDisclosures

N�None

TAVR vs. TAVITAVR vs. TAVI

�TAVR = Transcatheter Aortic Valve ReplacementReplacement

�TAVI = Transcatheter Aortic Valve Implantation

�TAVI seems to have won out in the literature

Objectivesj

�Introduction to TAVR/TAVIIntroduction to TAVR/TAVI�Familiarization with available and soon to be available valvessoon to be available valves�Review measurements performed on preoperative CT scanspreoperative CT scans�Review potential complications�Highlight developing applications

Aortic Stenosis

�Slowly develops but rapidly progresses after�Slowly develops, but rapidly progresses after symptom onset� 50% mortality within 2y of symptom onsety y y p

�Severe aortic stenosis defined as any of the Following:� Aortic Valve Area < 0.8 cm2

M A ti V l G di t 40 H� Mean Aortic Valve Gradient > 40 mmHg� Peak Aortic Jet Velocity > 4 m/sec

Aortic Stenosis

�Surgical replacement typically offers a low�Surgical replacement typically offers a low mortality cure�Up to 30 % of patients w/ AS are not surgicalUp to 30 % of patients w/ AS are not surgical

candidates�First transcatheter valve placed using an antigrade transeptal approach by Cribier and co-workers in 2002

�Currently, over 60,000 valves have been placed in over 40 countries

Transvascular Aortic Valve Replacement Planning:What Radiologists Need to Know Gregory D.N. Pearson, MD, PhD

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TAVI: how does it work?TAVI: how does it work?

N Engl J Med 2011; 364:2187-2198 N Engl J Med 2011; 364:2187-2198

Floroscopypy

N Engl J Med 2011; 364:2187-2198

Transapical approach

Edwards SAPIEN ValveEdwards SAPIEN Valve

http://www.edwards.com/products/transcathetervalve/pages/sapienthv.aspx

PARTNERPARTNER�Cohort A (Non-Surgical Patients � TAVR vs. V l l l t ) O t 2010Valvuloplasty) Oct. 2010

�Transcatheter Aortic-Valve Implantation for AorticTranscatheter Aortic Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

�Cohort B (TAVR vs. Surgery in High Risk Patients) June 2011

�Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

N Engl J Med 2010;363:1597-1607. N Engl J Med 2011; 364:2187-2198

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Cohort A (Non-Surgical Patients)Cohort A (Non Surgical Patients) � Multi-Center (21 centers, 17 in US)

� 358 patients with:� Severe Aortic Stenosis:

� Aortic Valve Area < 0.8 cm2

� Mean Aortic Valve Gradient > 40 mmHg� Mean Aortic Valve Gradient > 40 mmHg� Peak Aortic Jet Velocity > 4 m/sec

� Predicted > 50% mortality or severe morbidity at 30 days after potential surgery

E l i� Exclusion: � Bicuspid valve; LVEF < 20%; AV annulus < 18 mm or > 25 mm� Severe MR or AR; TIA/CVA within 6 mo; Severe renal insufficiency

� Randomized: � TAVR or Valvuloplasty

� Follow up at 30 days and 1 year� Follow-up at 30 days and 1 year

N Engl J Med 2010;363:1597-1607.

Cohort A (Non-Surgical Patients)Cohort A (Non Surgical Patients) 30 Days 1 Year

TAVRN=179

StndTxt N=179

P value

| TAVRN=179

StndTxt N=179

P value

Death (any cause) 9 5 0.41 | 55 89 <0.001

Death (CV cause) 8 3 0.22 | 35 75 <0.001

Re-Hospitalization 10 18 0.17 | 40 79 <0.001

Stroke 12 3 0.03 | 19 8 0.04|Any Death or Stroke 15 7 0.12 | 59 90 0.001

Vascular 55 9 <0.001 | 58 13 <0.001Complication

|Major Bleeding 30 7 <0.001 | 40 20 <0.001

N Engl J Med 2010;363:1597-1607.

Cohort A (Non-Surgical Patients)Cohort A (Non Surgical Patients)

�Summary

� At 1 year, TAVR showed significantly lower risk of death from CV and any cause� # needed to treat to prevent 1 death from AS = 5� # needed to treat to prevent 1 death or re-hospitalization = 3

� TAVR had Significantly more:� Strokes� Major Vascular Complications

M j Bl di� Major Bleeding

� TAVR patients experienced significant improvement symptoms� Based NYHA class I or II at 30 days 6 months and 1 year (all P < 0 001)� Based NYHA class I or II at 30 days, 6 months and 1 year (all P < 0.001)

N Engl J Med 2010;363:1597-1607.

Cohort B: High-Risk PatientsCohort B: High Risk Patients �Multicenter (25 centers, 22 in US)

�699 patients with:� Severe Aortic Stenosis (same criteria as Cohort A)� Severe Aortic Stenosis (same criteria as Cohort A)� High-Risk for Operative Complications:� Co-Existing conditions associated with > 15% risk of death w/n 30 days of

procedurep

�Randomized into:� Standard treatment: Surgical Replacement (N = 351)Standard treatment: Surgical Replacement (N 351)� TAVR (N = 348)� These were further split based on degree of PAD:

� Transfemoral approach (N = 244)pp ( )� Transapical approach (N = 104)

N Engl J Med 2011; 364:2187-2198

Cohort B: High-Risk PatientsCohort B: High Risk Patients � Primary endpoint was Death from any cause at 1 year

� TAVR = 24.2 % versus Surgical = 26.8% (P = 0.44)� Served to prove �Non-Inferiority� of TAVR in this High-Risk Population (P

0.001)

� TAVR again showed increased risk of Stroke at 30 days and 1 year� 30 days: 5 5% vs 2 4% (P = 0 04)30 days: 5.5% vs 2.4% (P 0.04)� 1 year: 8.3% vs 4.3% (P = 0.04)

C bi d i k f D th d St k t diff t (TAVR� Combined risk of Death and Stroke were not different (TAVR vsSurgery)� 30 Days: 6.9% vs 8.2%� 1 year: 26.5% vs 28.0%

N Engl J Med 2011; 364:2187-2198

Cohort B: High-Risk PatientsCohort B: High Risk Patients � TAVR had higher rates of Major Vascular Complications:

� 11.0% vs 3.2% (P<0.001)( )

� Surgery had higher rates of Major Bleeding and New-Onset A-Fib� 9.3% vs 19.5% (P<0.001) and 8.6% vs16.0% (P=0.006)

� TAVR had shorter ICU stay (3d vs 5d) & index hospitalization (8d vs 12d)

� At 30 days TAVR showed a significant reduction in NYHA symptomsAt 30 days, TAVR showed a significant reduction in NYHA symptoms � (Grade I or II), but this difference equalized at 1 year follow up

� At 1 year, TAVR had better valve function (Gradient and Valve Area)

� Significantly more aortic regurgitation after TAVR:� 30 Days: 12.2% vs 0.9%� 1 Year: 6 8% vs 1 9%1 Year: 6.8% vs 1.9%

N Engl J Med 2011; 364:2187-2198

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Company Valve Trials sizes annulus routes Femoral I t dIntroducerdiameter

Edwards Sapien PARTNER 23 mm26 mm

18-22 mm21-25 mm

Femoralapical

22 fr24 fr26 mm 21 25 mm apical 24 fr

Edwards Sapien XT PARTNER II 20 mm23 mm

16-19 mm18-21 mm

FemoralApical

ti16 fr

f26 mm29 mm

22-25 mm25-27 mm

aortic 18 fr20 fr

Edwards Sapien III 20 mm23 mm

16-19 mm18-21 mm

FemoralApical

14 fr14 fr

26 mm29 mm

22-25 mm25-27 mm

paortic 14 fr

16 frMedtronic CoreValve SURTAVI 23 mm

26 mm18-20 mm20 23 mm

FemoralApical

18 fr26 mm29 mm31 mm

20-23 mm23-26 mm26-29 mm

ApicalAorticSubclav.

Direct Flow Direct DISCOVER 25 mm 19-24 mm Femoral 18 frFlow SALUS 27 mm 22-26 mm 18 fr

Medtronic CoreValveMedtronic CoreValve

Valve comparison

Sapien valve CoreValve

Valve comparison

p

�Balloon expandable �Self-expanding�Round annulus�Annular valve

�Oval annulus�Supraannular valve

�Lower pacemaker risk (5 9%)

p�Higher pacemaker risk (22 5%)risk (5.9%) risk (22.5%)

Anatomy: how do we size valves?Anatomy: how do we size valves?

Preoperative imaging�Cardiac Catheterization�Cardiac Catheterization�Transthoracic and/or transesophageal echo�Cardiac CTCardiac CT�Gated, with systolic and diastolic phases�No � blockade

�Chest/Abdomen/Pelvis CT�Aortic runoff--with fast scanner can be performed

with same bolus as cardiac CTwith same bolus as cardiac CT

Schultz et al (Euro Heart Journal)Schultz et al. (Euro Heart Journal)� Three Dimensional Evaluation of the Aortic Annulus Using Multislice

CT: Are Manufacturer�s Guidelines for Sizing for Percutaneous Aortic Valve Replacement Helpful?Valve Replacement Helpful?

� 75 pts being evaluated for TAVR including a CT for pre-op planning� Only 50 received the valve (25 were too small / large for valve)

� Cardiologist picked valve based on:g p� Gender, body height, weight� LVOT and Aortic root on TTE and Aortography

� CT was performed and various measurements were obtained to find:� What was the best match between the cardiologist choice and manufacturer

European Heart Journal (2010) 31, 849�856

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MeasurementsRadiologists Cardiologists

http://sckhsmg2008.blogspot.com/2011/05/simple-echocardiography-views.html


How Did Schultz et al. Measure?How Did Schultz et al. Measure?� Step 1

� Establish sagittal (A) and coronal (B) planes tocoronal (B) planes to determine the obliquesagittal and coronal planes

� Step 2� Using oblique sagittal and

coronal planes to establish pcoaptation plane through the coronary cusps (C)

� Step 3� Using the coaptation plane

(C), scroll towards the h t i thi l t fi d

� Step 4� Using plane D, measure the

maximum and minimumheart in this plane to find the nadir of the cusps (D)

diameter of the aortic annulus


What did Shultz et al. Find?� Dmax � Dmean and DCSA were closest

to the cardiologists� choices f l

� Dmin

for valves� Only differing from the

cardiologists� choice by 26% and 24% of the time

� Dmean

and 24% of the time

� Assessed Adverse Outcomes� Trend when disagreement b/n

� �Mean from circumference� � Dcirc = Circ/�

� Trend when disagreement b/n Cardiologist & Manufacturer

� Chose too Small� Para-valvular aortic regurgitationcirc

� Mean Cross-Sectional Area� DCSA = 2 x � (CSA / �)

Para valvular aortic regurgitation� Device embolization

� Chose too Large� Aortic root ruptureCSA ( )


Cardiac CTA: what to report?

�Sapien valves:�Annular diameters�Annular area�Valve plane to coronary ostia distances�Agatston calcium score of the valve�LA or LV thrombus�IMA graft crossing midline (in case of SAVR)

Measurements


Annular cross-sectional area (CSA)(CSA)

�Area = 379 mm2�Dcsa = 22.0 mm

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Long and short axesLong and short axes

�Dmax = 25.9�Dmin = 20.1�Dmean = 23.0

Annular perimeterAnnular perimeter

�Perimeter=71.9 mm�Dcirc = 22.9 mm

Coronary sinus heightsCoronary sinus heights Agatston calcium score of valveAgatston calcium score of valve

�Orange = central valve calcification

�A score of � 1650 is highly correlated with severe stenosis in casesstenosis in cases where Echo is equivocalequivocal

CoreValve: what to measure?CoreValve: what to measure?

�Aortic annulus perimeter�Sinus of Valsalva�Sinus of Valsalva diameters

�Sinus of Valsalva perimeter�Sinus of Valsalva perimeter�Sinus of Valsalva heights�Sinotubular junction�Sinotubular junction diameters

Sinus of valsalva diameters and perimeterperimeter

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Sinus of Valsalva heightsSinus of Valsalva heights Sinotubular junction diametersSinotubular junction diameters


�Ascending aortic diameters�Ascending aortic diameters �3 cm above valve plane�For 23 mm valve, must be less than 34 mm

�4 cm above valve plane�For 26 mm valve, must be less than 40 mm

�For 29 and 31 mm valves, must be less than 43 mm


�Aortic angulation�Aortic angulation�Coronal viewF f l/ b l i t b�For femoral/subclavian access, must be <70°

�For transaortic access must be >30°�For transaortic access, must be >30

Aortic angulationAortic angulation

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Chest/abd/pelvis CT: what toChest/abd/pelvis CT: what to report?

�Porcelain aorta�Aneurysms�Minimal diameters�Aorta�Common iliacs�External iliacs�External iliacs�Common femorals

�Comorbid disease�Comorbid disease� tumors

What is a porcelain aorta?

S l l ifi d di t�Severely calcified ascending aorta and arch, precluding cross clamping

l tor replacement�Generally, dense circumferential or near-circumferential calcification of all or most of the ascending aorta

Porcelain aortaPorcelain aorta Common iliac measurementCommon iliac measurement

External iliac measurementExternal iliac measurement Common femoral measurementCommon femoral measurement

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Comorbid disease: PEComorbid disease: PE What are we doing at Columbiag� Standard here is to use TEE to obtain annulus measurements

� CTA cardiac� CTA cardiac � To assess aortic annulus size (End Diastole and Systole)� To assess annulus to coronary ostia distance (�jailing the artery�)

T d f V l l ifi ti� To assess degree of Valve calcification

� CTA Chest/Abdomen/Pelvis� To assess Aorta calcification� Assess the iliac and femoral artery anatomy� Best to have a � 8 mm vascular access to accommodate the loading system

ComplicationsComplications

�Stroke�Para-valvular aortic regurgitationg g�Heart block�Vascular injuryVascular injury�Device migration

Next Generation valvesValve Company InnovationsSapien 3 Edwards 14 fr introducer

Cuff to reduce paravalvular leakpCentera Edwards 14 fr introducer, repositionableSadra MedicalLotus

Boston Scientific Repositionable/retrievable prior to deployment Reduce paravalular leakLotus deployment. Reduce paravalular leak

Direct Flow Direct Flow Repositionable/retrievable prior to deployment. Reduce paravalular leak

Acurate TA Symetis Reduce paravalvular leakAcurate TA Symetis Reduce paravalvular leak.Stabilization arches

Portico St. Jude Repositionable. Anti-calcification. Decreased conduction system abnlDecreased conduction system abnl.

Engager Medtronic Transapical only. Low implant height to prevent interference with coronary ostiaostia

JenaValve JenaValve Transapical only. Repositionable/ retrievable prior to deployment.

Centera valveCentera valve

�Self-expanding p gnitinol

�Waist designed to ganchor in the annulus

Sapien 3 ValveSapien 3 Valve

�Balloon expandableBalloon expandable�External sealing ringring

�14 fr introducer

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Direct Flow valveDirect Flow valve

�Repositionable/Repositionable/ retrievable

�Cuff inflatable withCuff inflatable with polymer to conform to irregular annulus

Images of emerging transcatheter valve technology (valves with first-in-man data). a | Direct Flow Medical® valve (Direct Flow Medical, Santa Rosa, CA, USA). Permission obtained from Direct Flow Medical. b | HLT valve (Heart

Leaflet Technologies, Maple Grove, MN, USA). ©2011 HLT, Inc. a Bracco Group Co. c | Innovare valve (BraileLeaflet Technologies, Maple Grove, MN, USA). ©2011 HLT, Inc. a Bracco Group Co. c | Innovare valve (BraileBiomedical, São José do Rio Preto, Brazil). Courtesy of Diego Gaia, Federal University of São Paulo, Brazil. d | JenaValve® (JenaValve Technology, Munich, Germany). Permission obtained from JenaValve Technology. e |

Portico® valve (St-Jude Medical, St Paul, MN, USA). f | Sadra® Lotus Medical valve (Boston Scientific SciMedInc, Maple Grove, MN, USA). ©2011 Boston Scientific Corporation or its affiliates. All rights reserved. Used with permission of Boston Scientific Corporation. g | Symetis® Accurate valve (Symetis SA, Lausanne, Switzerland).

Permission obtained from Symetis. h | Engager® valve (Medtronic Inc., Minneapolis, MN, USA). ©2010 Medtronic, Inc. Image provided by Medtronic, Inc

Rodés-Cabau, J. (2011) Transcatheter aortic valve implantation: current and future approachesNat Rev Cardiol doi:10.1038/nrcardio 2011.164Nat. Rev. Cardiol. doi:10.1038/nrcardio.2011.164

Developing applicationsDeveloping applications

�Valve in valve aortic and mitral valve�Valve-in-valve aortic and mitral valve replacements

�Pulmonic valve�Pulmonic valve�Antiembolization devices

TMVR in mitral annuloplasty ringTMVR in mitral annuloplasty ring

Valve in valve TAVI and TMVIValve in valve TAVI and TMVIMelody transcatheter pulmonic valvevalve

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MRI safety

Ed d S i diti l 6�Edwards Sapien conditional 6�Edwards Sapien XT conditional 5�Medtronics Core Valve conditional 5�Direct Flow conditional 5Direct Flow conditional 5

�the list�, MRISafety.com

Special ThanksSpecial Thanks

�Dr. Mark Escudero�TAVR imaging teamTAVR imaging team�Dr. Anna Rozenshtien�Dr. Belinda D�Souza�Dr. Todd Pulerwitz�Dr. Andrew Einstein

�Other members of the TAVR team�Dr. Susheel Kodali �Dr. Omar Kahlique

transvascular aortic valve replacement planning: … are manufacturer s guidelines for sizing for...

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