Jonathon Leipsic MD FRCPC FSCCT. Vice Chairman of Radiology University of British Columbia. Disclosures

Transcription

1 Jonathon Leipsic MD FRCPC FSCCT Vice Chairman of Radiology University of British Columbia Disclosures Speaker s bureau: GE Healthcare and Edwards LifeSciences Grant Support- CIHR, GE Healthcare Advisory Board- GE Healthcare, Edwards LifeSciences, Vital Images Equity Stakeholder- TC3 1

2 Case 1- Reducing PAR with MDCT Clinical History 79 year old female STS score 13.5% - Declined for conventional Sx Chief complaint of worsening fatigue and SOB Decision made for transcatheter aortic valve replacement (TAVR) via transfemoral (TF) approach as part of the PARTNER Continued Access Registry PMHx: Severe Aortic Stenosis Hypertension Hyperlipidemia mid LAD PCI Pacemaker Medications ASA Clopidogrel Carvedilol Lisinopril Furosemide 2

3 Leon MB, Smith CR, Mack M et al. N Engl J Med 2010;363: Makkar et al. ACC 2012, NEJM 3

4 78 yo female severe aortic stenosis What are the current ECHO based recommendations? 26mm Valve 23mm Valve Usually tend to oversize by at least 2mm on echocardiography 4

5 Moderate PV Leak post Implant What Went Wrong?? 5

6 Mean diameter of-24.0mm and Area 5.18 cm 2 What we know about PV Leak Two main causes of PAR include under sizing of the transcatheter heart valve (THV) relative to the aortic annular size and incorrect device positioning (either too high or too low relative to the annular plane Treatment of severe PAR due to THV under sizing is challenging and typically unsuccessful Abdel-Wahab M, Zahn R, Horack M et al. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart

7 Aortic Annulus Annulus Sizing The aortic annulus is a complex 3 dimensional structure Previous anatomical studies established that the aortic annulus is a 3-pronged coronet rather than a circular structure It has three anchor points at the nadir of each aortic cusp Piazza N et al. Anatomy of the Aortic Root. Circ Cardiovascular Interventions The Annulus is Elliptical The annulus is commonly oval-shaped Reported in approximately 50% of Any patients single evaluated diameter for cannot TAVR adequately characterize the The mean annulus difference size between due to its coronal and sagittal measurements was 3.0 elliptical 1.9 non-circular mm configuration Tops LF, Wood DA, Delgado V, et al. Noninvasive evaluation of the aortic root with multislice computed tomography: implications for transcatheter aortic valve replacement. JACC Cardiovasc Imaging 2008; 3:

8 MDCT Provides Reproducible Measurements of the Annulus that provide a granular assessment of root geometry Advantages to MDCT methods Greater reproducibility (less operator dependent) Less sensitive to minor changes in obliquity 3 D 2D 8

9 Ring Creating the Basal Blanke, Schoepf and Leipsic- Radiology in press Example of Incorrect Plane Wrong Orientat Oblique Coronal Double Oblique Axial Oblique Sagittal 3D 9

10 CT Annular Measures Can Predict PV Leak Valve stent diameter Mean annular diameter MDCT AUC 0.84 Valve stent diameter Area-derived annular diameter MDCT AUC 0.86 Valve stent area/ Annular area MDCT AUC 0.87 Willson et al. JACC 2012 Incidence of PV Leak Willson et al. JACC April

11 Vancouver MDCT Sizing Guidelines Annular Area (mm 2 ) 26mm SAPIEN XT THV 400 NR 410 Balloon underfill 3cc 420 Balloon underfill 2-3cc 430 Balloon underfill 2 cc 440 Balloon underfill 2 cc 450 Balloon underfill 1cc RSNA 2012 in press JCCT Paravalvular regurgitation grade in patients where CT recommended a larger valve 70 85% had at least mild PAR In ncidence (%) % (6/40) 60% (24/40) 25% (10/40) 0 None/Trivial Mild Moderate/Severe Paravalvular regurgitation Leipsic et al RSNA 2012 and In press JCCT 11

12 Average percentage of annular over sizing (% over sizing = THV area / CT annular area) Oversized (%) 13.9 ± 8.0% vs 9.4 ± 17.4% TEE Sizing 33%(40/130) THVs P=0.01 were undersized. Undersized (%) CT TEE 10% THVs were oversized by >30% without annular rupture e The aortic annulus is larger in CT annular measurement Systole Diastole P value Mean (mm) 23.6 ± ± Area (cm 2 ) 4.7 ± ± 0.9 <0.01 Perimeter (mm) 78.5 ± ± Short diameter 20.8 ± ± (mm) Long diameter (mm) 26.6 ± ±

13 From Theoretical to Practical 13

14 Device Size Selection Aortic Annulus Ranges- Self Expanding Diameter Perimeter Area Range Range (mm) Range (mm) (mm 2 ) s Novel Valve In press JACC Interventions 14

15 5 center prospective trial evaluating the impact of MDCT based sizing on procedural outcomes- coming soon at ACC and RSNA Case 2 Vascular Injury 15

16 VARC Leon, Eur Heart J, (2): p Major Vascular Complication: PARTNER A+B: 15.3% Genereux, J Am Coll Card 2012; 60(12): PARTNERS-A (N=242) and B ( n=177): 64 (15.3%) major VC 50 (11.9%) minor VC within 30 days 16

17 Major Vascular Complications and Mortality Genereux, J Am Coll Card 2012; 60(12): Right common iliac dissection Borderline tortuous and calcified left iliofemoral system Minimum luminal diameter 6.8 mm on angiography and 5.8 mm on CT 17

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20 Peripheral Vessels: Assessment A thorough screening of the aorto- illiac and ilio-femoral regions must include: Vessel diameter Angiography alone is not sufficient MDCT and IVUS Vessel calcification MDCT, angiography, and IVUS Vessel tortuosity MDCT and angiography Ability of vessels to straighten should be assessed during diagnostic cath IVUS Aortogram Two-dimensional visualization Two- and threedimensional visualization (circumferential ) Calcification Vessel diameter Tortuosity MDCT 20

21 Learning Curve for Preventing Vascular Injury Variables P value MDCT Screening 44% 69% <0.01 Ultrasound-guided puncture 0 37% <0.01 Sheath size >19F 40% 2% <0.01 Expandable sheath 12% 18% 0.33 MLD < external sheath diameter 77% 30% <0.01 All vascular complications 32% 9% <0.01 Source: Toggweiler et al. J Am Coll Cardiol

22 Independent Clinical Predictors of Major VC. 137 patients Event rates at 30 days Toggweiler J Am Coll Card 2012; 59:113-8 Criteria to Predict Vascular Complications SFAR Variables >1.05 (n=55) <1.05 (n=72) P Value Any vascular 41.8% 16.7% < complication VARC Major 30.9% 6.9% VARC Minor 10.9% 9.7% Femoral artery complication 27.3% 12.5% Iliac artery 20.0% 0% 2.8% complication In-hospital mortality 20.0% 6.9% daymortality 18.2% 4.2% Source: Hayashida K et al. J Am Coll Cardiol 22

23 Aortoiliofemoral Complications SFAR Variables >1.05 (n=55) <1.05 (n=72) P Value Any vascular complication 41.8% 16.7% <0.001 VARC Major 30.9% 6.9% VARC Minor 10.9% 9.7% Femoral artery complication 27.3% 12.5% Iliac artery complication 20.0% 2.8% In-hospital mortality 20.0% 6.9% daymortality 18.2% 4.2% ILIOFEMORAL ACCESS Vascular complications have been reported and are largely attributable to the large device size and significant atherosclerosis Initial iliofemoral assessment with single plane angiography in the cath lab 23

24 MDCT allows assessment of a greater breadth of pathologies and anatomical structures Minimal luminal diameter Vessel tortuosity Burden and pattern of calcification Extent of atherosclerosis Other high-risk features including dissections and complex atheromas Thorough and complete three-dimensional assessment of the iliofemoral system 3-Dimensional Vascular Assessment 24

25 Identifies High Risk Features Aortoiliofemoral Tortuosity T t Tortuosity it can NOT be b assessed d on transverse t source images i Angle >90 b/w common and external iliac arteries = severe Stiff wire (e.g., Amplatz / Lunderquist) may straighten but kinks in sheaths may still occur Curvature of arterial centerline as inverse of curvature radius plotted as function along length of centerline path (e.g., endovascular AAA repair) 25

26 Case 3- Improving procedural success Clinical History 90 year old female, working as an office manager Chief complaint of progressive dyspnea Decision made for transcatheter aortic valve replacement (TAVR) via transfemoral (TF) approach as part of the PARTNER Continued Access Registry PMHx: Severe Aortic Stenosis Hypertension Hyperlipidemia mid LAD PCI Pacemaker Medications ASA Clopidogrel Carvedilol Lisinopril Furosemide 26

27 CT Assessment of Annular Size TEE: 21 mm CT: 22 mm CT: 18 x 24 mm CT Assessment of Annular Size 27

28 Assessment of Annular Size Valve Deployment 23mm Sapien 28

29 TEE Post Deployment TEE 29

30 Aortogram Post Deployment Review of Post TAVR Aortogram 30

31 Procedure Review TF-TAVR with 23mm Sapien via LFA Hypotension while preparing to close LFA TEE re-introduced: anular rupture at LCC Re-review of the aortogram confirmed that the diagnosis was missed at first evaluation Emergent cardiopulmonary bypass (RFA/RFV) Sternotomy and explantation of TAVR prosthesis Repair of left coronary sinus perforation and LVOT rupture, followed by CE #19 AVR What Went Wrong? 31

32 Incorrect Plane Wrong Orientation Oblique Coronal Double Oblique Axial Oblique Sagittal 3D Preventing Annular Injury with Preventing Annular Injury with DCT 32

33 Preventing extreme annular oversizing particularly in the setting of LVOT calcification 20.9 mm 427 mm mm A B 33

34 427 mm 2 A B Aortic Root Pseudoaneurysm 34

35 Blanke et al Conclusions Randomized data to date is supported by echocardiographic based sizing Annulus is almost uniformly non-circular and a reproducible 3-dimensional sizing tool such as MDCT is needed to accurately assess annular geometry MDCT has been shown to predict PAR and when integrated t into the THV selection process can reduce PAR CT can also help reduce the incidence of vascular and annular injury when performed correctly 35