PARAVALVULAR LEAK POST TAVR. Elements of Follow-up Post TAVR

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PARAVALVULAR LEAK POST TAVR David S Rubenson MD FACC FASE Founding Director, Cardiac Non-Invasive Laboratory Scripps Clinic Medical Group number 1 Elements of Follow-up Post TAVR JACC CV Imag 2016;9:193 number 2 1

An 86 yo patient post TAVR has moderate to severe persisting dyspnea due to CHF prompting TEE evaluation to assess aortic valve function. A 2D image of the aortic valve in short axis is shown. The most appropriate and accurate method to assess the magnitude of PVR in this patient would be: 1. AI pressure half-time 2. Quantitative doppler calculation of PISA derived regurgitant volume 3. The Senning index 4. Percent circumference method using color doppler 5. A multi-parametric approach number 3 An 86 yo patient post TAVR has moderate to severe persisting dyspnea due to CHF prompting TEE evaluation to assess aortic valve function. A 2D image of the aortic valve in short axis is shown. The most appropriate and accurate method to assess the magnitude of PVR in this patient would be: 1. AI pressure half-time 2. Quantitative doppler calculation of PISA derived regurgitant volume 3. The Senning index 4. Percent circumference method using color doppler 5. A multi-parametric approach number 4 2

PARAVALVULAR AI INCIDENCE Marked inconsistencies in data MODERATE/SEVERE: 0-24% MILD : 7-70% Potential Causes Baseline risk profile of the population Type of THV and implant approach Method of assessment Criteria applied in grading number 5 Scripps Clinic Experience 2012 2017 1795 patients Mod/Severe 12% number 6 3

CLINICAL IMPACT OF AI (including valvular and paravalvular) Registry Data JACC 2013;61:1585 Studies from 2002-2012 13,000patients CoreValve 5200 Edwards 7200 3X increase mortality at 30 days (mod/severe) 2.3X increase mortality 1 year (mod/severe) Outcomes less clear in mild AI (other studies) number 7 CASE 1: 85 y/o male Severe symptomatic AS progressive CHF AVA 0.6cm2, gradient 97/53mmHg, PAP 61mmHg LV EF 47% Additional History Moderate MR Paroxysmal AF Hx VT - S/P AICD Diabetes Non-obstructive CAD History of CVA with mild cognitive impairment number 8 4

Transfemoral TAVR 26mm Sapien Cusp Insertion 24.5mm Cover Index 5.7% number 9 Immediate post implant mod/sev AI (paravalvular and valvular) Post dilated improved slightly number 10 5

CLINICAL COURSE Immediate post implant mod/sev AI (paravalvular and valvular) Post dilated improved slightly Readmitted 1 month with acute CHF EF decline to 31%, increased AI Re-do TAVR with 26mm Valve-in-valve Improved central AI, persisting paravalvular AI Amplatzer closure of post paravalvular leak Discharged improved number 11 CASE 2: 93 y/o female Severe AS with recurrent HF NEF AVA 0.54cm2, Gradients84/50mmHg, PA 42mmHg LV EF 84% Additional History Mod-severe MR Paroxysmal atrial fibrillation Remote breast CA number 12 6

number 13 Transfemoral TAVR 23mm Sapien Cusp Insertion 19mm Cover Index 17% Unstable immediately post deployment Diffuse ST elevations Increased PA pressure to 80/50mmHg Severe valvular AI number 14 7

number 15 number 16 8

Immediate deployment 23mm Sapien Valve-in-Valve number 17 MECHANISMS OF POST IMPLANT AORTIC REGURGITATION Sinning et al JACC 2012;59:1134 number 18 9

PREDICTING POST TAVR AI Moderate or severe AI 5-22% Important determinants: Undersizing the prosthesis Extent of calcification of the valve complex Prosthesis position in relationship to the annulus Cover Index : Prosthesis diam - Cusp Insertion diam Prosthesis diam Mod or greater AI not seen if > 8% (JACC Intv 2009;2:821) number 19 91yo male.severe sx AS and interstitial lung disease. TAVR valve size 26mm based on 2D echo annular dimension of 22mm number 20 10

83y/o male; TAVR for extreme surg risk with severe COPD, OSA and R diaphragm paralysis Annulus 2.2cm Annulus area = 380mm2, perimeter 69mm number 21 MULTIPLANAR RECONSTRUCTION Confirming the aortic root size saggital transverse 3D TEE Saggital 2.29 Coronal 2.55 coronal number 22 11

CT: 1 or 2 valve sizes larger Annulus 33x21mm Area 586mm2 Perimeter 88mm number 23 Prediction Indices TAVI echo calcification score (TAVIECS) Aortic root Mitral annulus Aortic valve cusps Aortic valve commissures Aortic annulus Sinotubular junction Allowed prediction of the risk of postoperative paravalvular and overall aortic regurgitation Colli et al. J Thor Cardiovasc Surg 2011;142:1229 number 24 12

TEE Findings before the TAVR Bulky Calcification Uncertain Prosthesis Sizing 2.7cm 2.35cm number 25 Aortic Root/Annular Calcium JACC: CV Imag 2013;6:249 number 26 13

Unbehaun et al. JACC 2012;59:211 number 27 Heavy MAC extending into the LVOT number 28 14

Morphological Risk Factors for Post Procedural AI modification of implant strategy Unbehaun et al. JACC 2012;59:211 number 29 82 yo male. Severe sx AS with EF 66% Heavy aorto-iliac Ca++ 26mm Edwards Sapien THV via anterior thoracotomy number 30 15

Post Implant Appearance number 31 Immediate Intraprocedural TAVR Assessment number 32 16

GRADING POST PROCEDURE AI Percent Circumference Criteria Subjective; high inter/intra observer variability High reported incidence of 3-4+ AI (not confirmed CMR etc) Multiparametric Approach (JACC CV Imag 2015;8:340) Hemodynamic assessment (Senning index) Structural parameters Color doppler (multiple views) jet width at origin Beware P1/2 time (compliance effects) and PISA Quantitative doppler (regurg vol from RV LV stroke vols) Cardiac MRI number 33 JACC CV Imag 2015;8:340 number 34 17

Jet location - TTE views JACC CV Imag 2015;8:340 number 35 CAREFULLY INSPECT THE VALVE May require off-axis imaging JACC Imag 2016;9:193 number 36 18

Rotational sweeps to locate the jets JACC CV Imag 2015;8:340 number 37 Grading Post Implant AI Transgastric TEE Multiple views number 38 19

Quantifying Post Procedural AI JACC Img 2012;5:441 number 39 CIRCUMFERENTIAL EXTENT JACC CV Imag 2015;8:340 JACC CV Imag 2015;8:340 number 40 20

Post TAVR Paravalvular Leak Circumference Assessment TTE TEE number 41 Circumferential Extent Only an approximate guide Multiple jets often present; cannot image in single plane Jets often eccentric, cross parallel to SAX and appear larger Calcifications may shadow the jets Jet width by color is dependent on gain, aliasing velocity and image quality number 42 21

Eccentric Anterior PVR jet JACC CV Imag 2015;8:340 number 43 PVR Jet Features Associated with Regurgitation Severity Large jet width at origin Visible PISA Abnormal THV stent shape with mal-apposition Large vena contracta Multiple jets in several views JACC CV Imag 2015;8:340 number 44 22

AORTIC REGURGITATION INDEX (Sinning) JACC 2013;62:11 number 45 RESOLVING DISCORDANT CLINICAL VS ECHO FINDINGS JACC CV Imag 2016;9:193 number 46 23

CMRI IMAGING JACC CV Imag 2015;8:340 number 47 INTRAPROCEDURAL MANAGEMENT OF PVR JACC CV Imag 2015;8:340 number 48 24

84 yo male severe AS with Class 3-4 HFpEF. Multiple medical problems. Initial BAV with improvement. Sx recurred. 26 mm Edwards Sapien THV number 49 Significant PVR identified Post dilation attempted number 50 25

Closure of Post TAVR Paravalvular Leak 6mm Amplatzer Vascular Occluder number 51 Intrtaprocedural Guidance with RT 3-Dimensional TEE number 52 26

Final Result Pre-closure Post-closure number 53 JACC Interv 2015;8:681 number 54 27

JACC Interv 2015;8:681 number 55 3-D Printed tissue-mimicking phantom of the aortic root CT used as source data TAVR simulation with in- vitro deployment Aortic root strain quantified Annular bulge calculated Predicted post-tavr PVR JACC CV Imag 2017;10:719 number 56 28

JACC Imag 2015;8:1364 number 57 Scripps Experience 2012 2017 N = 929 patients N = 866 patients 29

JACC 2017;70:3137 number 59 JACC 2017;70:3127 number 60 30

SUMMARY TAVR preferred option for high risk and inoperable patients FDA approval 2016 for intermediate risk patients PVR > mild at 1 year is higher for TAVR vs SAVR Significantly increased mortality associated with PVR Accurate quantitation of PVR is difficult Mild PVR may have less detrimental impact Clinical impact variable based on patient factors Newer devices and procedures reduce incidence Management techniques to correct PVR are evolving number 62 31