Corrado Tamburino, MD, PhD

Transcription

1 Paravalvular leak: acceptable or not Corrado Tamburino, MD, PhD Full Professor of Cardiology, Director of Postgraduate School of Cardiology Chief Cardiovascular Department, Director Cardiology Division, Interventional Cardiology and Heart Failure Unit, University of Catania, Ferrarotto Hospital, Catania, Italy

2 Disclosure Statement of Financial Interest I, Corrado Tamburino, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation

3 Just a cosmetic issue?

4 What we have learnt Very common finding after TAVI Usually trivial or mild Multimodal degree quantification Long-term impact

5 Roadmap of the lecture What is the incidence? Is it associated with worse outcomes? Is it predictable? How to manage it?

6 Incidence, ES & CRS % % 10-30% No PVL Any PVL Grade 2 PVL Rajan et al. Catheter Cardiovasc Interv 2009 Clavel et al. J Am Coll Cardiol 2009 Jilaihawi et al. Eur Heat J 2009 Himbert et al. J Am Coll Cardiol 2008 Moss et al. JACC Cardiovasc asc Imag 2008 Detaint t et al. JACC Cardiovasc asc Interv 2009

7 Incidence, Edwards-SAPIEN European PARTNER 47.0% REVIVAL SOURCE 1.9% 22.9% 18.7% 58.4% PARTNER cohort A 12.2% PARTNER cohort B 11.8% 42.0% 46.0% 0% 20% 40% 60% moderate < moderate No

8 Incidence, CoreValve Nuis et al. 13.0% Takagi et al. 20.3% 26.6% 53.1% Buellesfeld et al. 6.0% 42.0% 52.0% Tamburino et al. 21.0% 0% 20% 40% 60% moderate < moderate No

9 Incidence, ES & CRS Eltchaninoff et al. 9.5% Zahn et al. 17.5% 27.6% 54.9% German Registry 17.2% 27.7% 55.1% UK Registry 13.6% 39.0% 47.4% 0% 20% 40% 60% moderate < moderate No

10 Impact on outcomes Tamburino et al. Circulation 2011

11 Impact on outcomes nts) PPL at 1 year (% of actua arial numb er of patie 100% 80% 60% 40% 20% 0% N=661-20% PV 0+ PV 1+ PV 2+ PV 3+ PV 4+ Post-procedural aortic regurgitation grade AR none AR 1+ AR 2+ AR 3+ AR 4+ Same or better worse Tamburino et al. Circulation 2011

12 Impact on outcomes Overall mortality Hazard ratio 95% LCL 95% UCL p value Intraprocedural stroke Pre-procedural mitral regurgitation 3+ or Systolic pulmonary artery pressure > 60 mmhg Prior acute pulmonary edema Diabetes mellitus Early mortality Odds ratio 95% LCL 95% UCL p value Conversion to open heart surgery Cardiac tamponade Major access site complications Left ventricular ejection fraction < 40% Prior balloon aortic valvuloplasty Diabetes mellitus Late mortality Hazard ratio 95% LCL 95% UCL p value Prior stroke Post-procedural paravalvular leak Prior acute pulmonary edema Chronic kidney disease Tamburino et al. Circulation 2011

13 Impact on outcomes AR index=[(dbp -LVEDP)/SBP] x consecutive TAVI with Medtronic CoreValve PVL assessed by Echo, angio, and measurement of the AR index Patients with AR index <25 had a significantly increased 1-year mortality risk compared with patients with AR index 25 Sinning et al., J Am Coll Cardiol 2012

14 Impact on outcomes AR index <25 AR index >25 Mo ortality (%) ,8% 75 None/mild periar p (log rank-test) < 0,001 Hazard Ratio (95% CI) = 3,89 (2,02-7,49) 36,4% Moderate/severe periar Time (days) Mortality (%) p (log rank-test) < 0,001 Hazard Ratio (95% CI) = 2,97 (1,57-5,63) 83,3% None/mild periar 54,0% Moderate/severe periar Time (days) Sinning et al., J Am Coll Cardiol 2012

15 Kodali et al., NEJM 2012

16 Is it predictable? Annulus measurement Calcium burden evaluation Operator experience MSCT is mandatory!!!

17 Aortic root anatomy not so simple! Piazza N, Circ Cardiovasc Interv 2008;1:

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19 Aortic root anatomy and lot of calcium!

20 Heavy calcifications prosthesis underexpansion

21 Is it predictable? Détaint et al. JACC Cardiovasc Interv 2009

22 Is it predictable? Détaint et al. JACC Cardiovasc Interv 2009

23 Is it predictable? MDCT mean diameter (0.81, 95%CI: ), MDCT area (0.80, 95%CI: ), TEE diameter (0.70, 95%CI: ). 0 Willson et al. J Am Coll Cardiol 2012

24 Is it predictable? Undersized prosthesis 4,5 Annulus size 3,5 4,5 p Operator Experience 1,4 Calcification 2,3,6 PVL Cover index 4 1 Detaint et al. JACC Interv Coli et al. Circulation Willson et al. J Am Coll Cardiol Takagi et al. Catheter Cardiovasc Interv Delgado et al. Circulation John et al. JACC Cardiovasc asc Interv

25 How to prevent it? 1. Accurate aortic root assessment MSCT has to be the preferred tool 2. Oversize the device Pay attention to damage on the aortic root

26 How to prevent it? Babaliaros et al. JACC Cardiovasc Interv 2011

27 How to manage it? No doubt...it has to be treated!

28 How to manage it? 1. Post-dilatation... dilatation...crs & ES 2. Snaring...CRS 3. Valve-in-Valve... Valve...CRS & ES 4. Anchoring balloon...es

29 How to manage it? Para-valvular Leak Frame Postdilatation underexpansion lower deployment with Snaring Valve-in in-valve Technique e respect to the annulus undersized device with Postdilatation or ViV is respect to the aortic futile annulus higher deployment with Valve-in in-valve respect to the annulus

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32 Conclusions Mild PVL complicates the majority of TAVI procedures Accurate aortic root evaluation is mandatory (MSCT) Prefer oversize prosthesis but be careful! Work now should be directed toward reducing PVL with improved device designs, techniques for more precise valve sizing and positioning, and judicious use of post- TAVI dilation