Post-Procedural Aortic Regurgitation in Balloon-expandable and Self-Expandable TAVR Procedures: Analysis of Predictors and Impact on Long-Term Mortality: Insights from the FRANCE2 Registry

Background — Significant post-procedural-aortic-regurgitation (AR) is observed in 10-20% of cases after TAVR. The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear. Methods and Results — TAVR was performed in 3,195 consecutive patients at 34 hospitals. Post-procedural-transthoracic echocardiography (TTE) was performed in 2,769 (92%) of the eligible population and constituted the study group. Median follow-up was 306 days (Q1-Q3=178-490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or non-femoral (24.7%). A post-procedural-AR (cid:149) Grade2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%,p=0.0001). Extensive multivariable analysis confirmed that use of a SE device was one of the most powerful independent predictor of post-procedural-AR (cid:149) Grade2. For BE-TAVR, 8 independent predictors of post-procedural-AR (cid:149) Grade2 were identified including femoral delivery (p=0.04), larger aortic annulus (p=0.0004) and smaller prosthesis diameter (p=0.0001). For SE-TAVR, two independent predictors were identified including femoral delivery (p=0.0001). Aortic annulus and prosthesis diameter were not predictors of post-procedural-AR for SE-TAVR. A post-procedural-AR (cid:149) Grade2, but not a post-procedural-AR=Grade1, was a strong independent predictor of one-year mortality for BE (HR=2.50;p=0.0001) and SE-TAVR (HR=2.11;p=0.0001). While Post-procedural-AR (cid:149) Grade2 was well tolerated in patients with AR (cid:149) Grade2 at baseline (one-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR<Grade2 at baseline (31%), low trans-aortic gradient (35%) or non-femoral delivery (45%). Conclusions — Post-procedural-AR (cid:149) Grade2 was observed in 15.8% of successful TAVR and was the strongest independent predictor of one-year mortality. The use of the SE device was a powerful independent predictor of post-procedural-AR (cid:149) Grade2. iiiss pprroococtotorr aaand d iiss g prococtotor fofor r MeMedtdrooninic c and d receceiviveded grantntss frfromom EEdwwarardsds-L-Lififee Sccieiencnce.e. r isis MeMeMeddidcacal.ll EEEmmmmmananueueulll TeTeTeigigig rerer iis prpprococctototorrr dd isisis rereecececeiviviininng gg grgrgranananttsts moortrtalalitity trtrannscscataheteter aoaortrticic valvee iimpmplalantntataion.n

[1]  Antonio Colombo,et al.  Clinical ResearchInterventional CardiologyIncidence, Predictors, and Outcomes of Aortic Regurgitation After Transcatheter Aortic Valve Replacement: Meta-Analysis and Systematic Review of Literature , 2013 .

[2]  P. Pibarot,et al.  Comparison of hemodynamic performance of self-expandable CoreValve versus balloon-expandable Edwards SAPIEN aortic valves inserted by catheter for aortic stenosis. , 2013, The American journal of cardiology.

[3]  Bernard Chevalier,et al.  Impact of post-procedural aortic regurgitation on mortality after transcatheter aortic valve implantation. , 2012, JACC. Cardiovascular interventions.

[4]  G. Nickenig,et al.  Impact of paravalvular leakage on outcome in patients after transcatheter aortic valve implantation. , 2012, JACC. Cardiovascular interventions.

[5]  J. Després,et al.  Impact of metabolic syndrome on progression of aortic stenosis: influence of age and statin therapy. , 2012, Journal of the American College of Cardiology.

[6]  P. Leprince,et al.  Registry of transcatheter aortic-valve implantation in high-risk patients. , 2012, The New England journal of medicine.

[7]  Scott Lim,et al.  Two-year outcomes after transcatheter or surgical aortic-valve replacement. , 2012, The New England journal of medicine.

[8]  P. Pibarot,et al.  Predictive factors, efficacy, and safety of balloon post-dilation after transcatheter aortic valve implantation with a balloon-expandable valve. , 2012, JACC. Cardiovascular interventions.

[9]  R. Hetzer,et al.  Transapical Aortic Valve Implantation Incidence and Predictors of Paravalvular Leakage and Transvalvular Regurgitation in a Series of 358 Patients , 2011 .

[10]  Pascal Vranckx,et al.  Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. , 2012, Journal of the American College of Cardiology.

[11]  A. D. Cunningham,et al.  Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. , 2011, Journal of the American College of Cardiology.

[12]  O. Alfieri,et al.  VALVULAR AND STRUCTURAL HEART DISEASES Original Studies Predictors of Moderate-to-Severe Paravalvular Aortic Regurgitation Immediately After CoreValve Implantation and the Impact of Postdilatation , 2011 .

[13]  G. Schuler,et al.  Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry , 2011, Heart.

[14]  F. Maisano,et al.  Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis , 2011, Circulation.

[15]  P. Serruys,et al.  Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium , 2010, European heart journal.

[16]  R. Tölg,et al.  Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. , 2010, Journal of the American College of Cardiology.

[17]  J. Després,et al.  Age-related differences in the pathogenesis of calcific aortic stenosis: the potential role of resistin. , 2010, International journal of cardiology.

[18]  Fabien Hyafil,et al.  Multimodal assessment of the aortic annulus diameter: implications for transcatheter aortic valve implantation. , 2010, Journal of the American College of Cardiology.

[19]  J. Zamorano,et al.  European Association of Echocardiography recommendations for the assessment of valvular regurgitation. Part 1: aortic and pulmonary regurgitation (native valve disease). , 2010, European journal of echocardiography : the journal of the Working Group on Echocardiography of the European Society of Cardiology.

[20]  Alec Vahanian,et al.  Determinants of significant paravalvular regurgitation after transcatheter aortic valve: implantation impact of device and annulus discongruence. , 2009, JACC. Cardiovascular interventions.

[21]  Bijoy K Khandheria,et al.  Recommendations for evaluation of prosthetic valves with echocardiography and doppler ultrasound: a report From the American Society of Echocardiography's Guidelines and Standards Committee and the Task Force on Prosthetic Valves, developed in conjunction with the American College of Cardiology Card , 2009, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[22]  J. Lodder,et al.  Cardiac valve calcification: characteristics of patients with calcification of the mitral annulus or aortic valve , 1997, Heart.