Paravalvular Regurgitation is a Risk Factor Following TAVI
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1 Paravalvular Regurgitation is a Risk Factor Following TAVI Philippe Pibarot, DVM, PhD, FACC, FESC, FASE Canada Research Chair in Valvular Heart Disease INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUÉBEC Université LAVAL
2 Disclosure Philippe Pibarot Financial relationship with industry: Edwards Lifesciences: Echo CoreLab for PARTNER II - SAPIEN 3 and TAVR-UNLOAD V-Wave: Echo CoreLab Cardiac Pheonix: Echo CoreLab Other financial disclosure: Research Grants from Canadian Institutes of Health Research and Heart & Stroke Foundation of Quebec Off label Use: None
3 PVR TAVR
4 Incidence of Moderate/Severe PVR in TAVR Pibarot et al. JACC CV Imaging; 8: , 2015
5 Impact of Paravalvular Regurgitation on 2-Year Outcomes: PARTNER-I A Trial Paravalvular Regurgitation Total (Paravalvular+Central) Regurgitation Kodali et al. NEJM 2012;366:
6 Impact of AR on Mortality CoreValve Pivotal Trial Popma et al. JACC 2014
7 Impact of AR Post-TAVI / France-2 Registry n= 2769 Van Belle et al. Circulation 2014
8 Impact AR Post-TAVI / UK Registry Dworakowski R, et al. Heart 2014
9 Impact of Moderate / Severe Aortic Regurgitation After TAVI Meta-Analysis and Systematic Review of Literature Impact of Moderate-Severe AR on Mortality Athappan et al. J Am Coll Cardiol 2013;61:
10 Impact of Mild AR on Mortality after TAVI: A Meta-analysis Athappan et al. J Am Coll Cardiol 2013;61:
11 Survival Under Conservative Management After Diagnosis of Native AR Detaint D et al. J Am Coll Cardiol Img 2008;1:1 11
12 Potential explanations for the Association between Mild PVR and mortality following TAVI Patients with mild PVR have worse baseline risk profile compared to none/trace PVR Severity of PVR is underestimated Some subsets of patients with severe AS may be more vulnerable to AR
13 Predictors of Paravalvular Regurgitation following TAVI Male gender NYHA Class IV Atrial fibrillation AR at baseline MR at baseline More severe and asymmetric valve calcification Larger aortic annulus Smaller cover index Inadequate valve positioning Self expending valve Sinning et al. JACC, 2012 Haensig M, EJCTS, 2012 Ewe et al. Am J Cardiol 2011 Ubehaum et al. JACC, 2012 Sinning et al. JACC 2013
14 Baseline Characteristics of TAVR Patients with Paravalvular Regurgitation in the PARTNER Trial Kodali et al. Eur Heart J 2014
15 Impact of PVR on Mortality in the PARTNER Trial Kodali et al. Eur Heart J 2014
16
17 Grading Severity of Paravalvular Regurgitation Bloomfield; JACC Img; 5:441 55, 2012
18 Total Aortic Regurgitation PARTNER I versus PARTNER II-B PARTNER-IA PARTNER-IIB
19 Grading of Paravalvular Regurgitation by Circumferential Extent of the Jet ASE Guidelines & PARTNER II Trial: Mild PVL VARC 2 & PARTNER I Trial: Mild PVL <10% of the sewing ring Mild PVL <10% of the sewing ring Moderate PVL Moderate PVL 10-20% of the sewing ring Moderate PVL 10-30% of the sewing ring Severe PVL >20% of the sewing ring Severe PVL Severe PVL >30% of the sewing ring Zoghbi WA et al. J Am Soc Echocardiography 2009;22(9): Douglas PS et al. J Am Soc Echocardiography 2013;26(4):
20 Multi-window Imaging is Key!
21 Pibarot et al. JACC CV Imaging; 8: , 2015
22 Multi-View/Multi Parametric TTE versus CMR to Assess AR Following TAVR Ribeiro HB, et al. Heart, 2014
23 Impact of Paravalvular Regurgitation on 2-Year Outcomes: PARTNER-I A Trial Paravalvular Regurgitation Total (Paravalvular+Central) Regurgitation Kodali et al. NEJM 2012;366:
24 Effect of Acuteness of AR on Mortality After TAVI: Multicenter Study (1735 Patients) Jerez-Valero et al. J Am Coll Cardiol Intv 2014;7:
25 Effect of Acuteness of AR on Mortality After TAVI: France 2 Registry Van Belle et al. Circulation 2014
26 A moderate PVR may be well tolerated by a patient with pre-existing native AR
27 A mild PVR could be harmful in patients with pure AS
28 New Transcatheter Heart Valves to Prevent PVR
29 Moderate/Severe PVR at 30 Days Edwards SAPIEN Valves PARTNER I and II Trials 2.5% 3.8 % SAPIEN SAPIEN XT SAPIEN 3
30 Paravalvular Regurgitation Paired Analysis 100% % Severe 60% 40% 20% p = Moderate Mild None / Trace 0% # of Patients 30 Days 1 Year
31 Survival (%) 1 Year KM Survival by 30-Day PVL 100% 80% No statistical difference between None/Trace and Mild. 88.0% N / T 85.9% Mild 60% 61.9% M / S 40% 20% Overall: Log-Rank p-value = M / S vs N / T: Log-Rank p-value = M / S vs Mild: Log-Rank p-value = % Numbers at Risk Months None / Trace Mild Mod / Severe
32 Ventriculography after THV Deployment No AR Any degree of AR TEE / TTE for quantitation of AR severity and identification of AR location (paravalvular vs. central) and etiology Trace Mild Moderate Severe Presence of vulnerability factors to AR and/or Absence of risk factors for complications with corrective procedures No More Procedures No Yes Corrective Procedures Balloon post-dilation Valve-in-valve Closure of the leak with a plug Reassess
33 Conclusions Moderate/severe PVR occurs in 2-15% of patients and is an independent predictor of mortality Severe PVR is a powerful risk factor for mortality Moderate PVR is generally associated with worse outcomes but may be better tolerated in patients with pre-existing native AR
34 Conclusions Mild PVR is frequent (7-70%) following TAVI and is generally well tolerated Mild PVR may have an impact on mortality if it is underestimated or if it occurs in a patient with no pre-existing AR and/or restrictive LV physiology Decision to perform additional corrective procedures should be individualized according to: severity of PVR, vulnerability factors to AR, and risk factors for complications
35 IF YOU FAIL TO PREPARE BE PREPARED TO FAIL! Winston Churchill
Mild paravalvular regurgitation is not an independent predictor of mortality following TAVI
Mild paravalvular regurgitation is not an independent predictor of mortality following TAVI Philippe Pibarot, DVM, PhD, FACC, FAHA, FASE Canada Research Chair in Valvular Heart Diseases INSTITUT UNIVERSITAIRE
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