Facteurs prédic.fs de mauvais pronos.c à court terme après TAVI

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1 Facteurs prédic.fs de mauvais pronos.c à court terme après TAVI Auffret V., Bedossa M., Donal E., Boulmier D., Laurent M., Mabo P., Verhoye JP., Beneux X., Sost G. et Le Breton H. GRCI 29/11/12

2 Leon MB et al. N Engl J Med 2010 Vahanian A.et al. Eur Heart J 2012 Smith CR et al. N Engl J Med 2011 Holmes DR Jr. et al. J Am Coll Cardiol 2012

3 Gilard M et al. N Engl J Med 2012

4 Objec.f IdenIficaIon de facteurs pré- opératoires prédicifs de mauvais résultat à 6 mois après TAVI PaIents soris vivants après TAVI Mauvais résultat = critère composite Décès entre la sorie et M6 Classe NYHA III ou IV à M6 HospitalisaIon pour IC ou SCA ou AVC

5 1 Patient died before multidisciplinary team reunion Intraprocedural death n=2 Death during the iniial hospitalizaion n=5 Unsuccessful implantation n= 4 Conversion to surgery n=1 Patients referred to our institution for pre-tavi evaluation from January 2009 to October 2011 n=368 Multidisciplinary team reunion Patients undergoing TAVI n=125 Patients discharged with a transcatheter-implanted aortic valve. n= 113 Medically treated patients n= 172 Balloon aortic valvuloplasty n=26 Surgically treated patients n= 33 Further investigations needed before final decision n=11 Surviving patients n=103 Patients who died n=10 Death from other causes n= 1 Hemorrhagic shock due to gastrointestinal bleeding N=1 Cardiovascular death n=9 End-stage heart failure n=4 Good outcomes group n=75 Poor outcomes group n=38 Unwitnessed sudden death n=4 SepIc shock due to infecive endocardiis n=1 Figure 1- Flowchart presenting all patients referred for TAVI and the generation of study patients

6 Résultats sur 125 procédures Mortalité à J % Mortalité à 6 mois 13.6% Durée moyenne de procédure 101.1±31.5 min Succès de procédure 118 (94.4%) Abord : TF / SC / TA / Trans- aorique 100 (80%) / 10 (8%) / 9 (7.2%) / 6 (4.8%) Conversion chirurgicale 2 (1.6%) Nécessité d implantaion d une 2 ème valve 2 (1.6%) ComplicaIon vasculaire majeure 12 (9.6%) Saignement menaçant le pronosic vital 3 (2.4%) Saignement majeur 29 (23.2%) AVC 3 (2.4%) Tamponnade 1 (0.8%) Insuffisance rénale sévère (AKI 3) 9 (7.2%) ImplantaIon de PM 13 (10.4%) Durée moyenne d hospitalisaion en USIC / totale 3.8±2.3j / 9.7±6.1j

7 Table 1- Clinical and biological characteris.cs of the study pa.ents at baseline. Characteris.cs All pa.ents (n=113) Good outcomes pa.ents (n=75) Poor outcomes pa.ents (n=38) p- value Age - yr Male sex - no. (%) Body surface area- m² LogisIc EuroSCORE - % Society of Thoracic Surgeons score - % NYHA class III or IV - no. (%) Angina pectoris- no. (%) Syncope- no. (%) Previous acute heart failure- no. (%) Clinical history - no. (%) Coronary artery disease Previous PCI Previous balloon aoric valvuloplasty Previous CABG Previous surgical aoric valve replacement Cerebrovascular disease Peripheral vascular disease Porcelain Aorta Atrial fibrillaion Right bundle branch block Permanent pacemaker Chest- wall irradiaion Hypertension Diabetes mellitus Chronic obstrucive pulmonary disease Chronic kidney disease- no. (%) Moderate chronic kidney disease Severe chronic kidney disease NT pro- BNP- pg/ml Edwards SAPIEN valve- no. (%) Transapical or transaortic approach-no. (%) 79.7± (51.0) 1.75± ± ± (77.9) 23 (20.4) 14 (12.4) 63 (55.8) 60 (53.0) 14 (12.4) 24 (21.2) 20 (17.7) 1 (0.9) 21 (18.6) 24 (21.2) 5 (4.4) 29 (25.7) 8 (7.1) 13 (11.5) 15 (13.3) 79 (69.9) 20 (17.7) 47 (41.6) 46 (40.7) 5 (4.4) ± (57.5) 13 (11.5) 78.4± (45.3) 1.73± ± ± (73.3) 18 (24.0) 13 (17.3) 40 (53.3) 45 (60.0) 10 (13.3) 12 (16.0) 15 (20.0) 1 (1.3) 14 (18.7) 18 (24.0) 4 (5.3) 11 (14.7) 2 (2.7) 9 (12.0) 13 (17.3) 49 (65.3) 14 (18.7) 27 (36.0) 30 (40.0) 4 (5.3) ± (66.7) 11 (14.7) 82.2± (63.2) 1.80± ± ± (86.8) 5 (13.2) 1 (2.6) 23 (60.5) 15 (39.5) 4 (10.5) 12 (31.6) 5 (13.2) - 7 (18.4) 6 (15.6) 1 (2.6) 18 (47.4) 6 (15.8) 4 (10.5) 2 (5.3) 30 (78.9) 6 (15.8) 20 (52.6) 16 (42.1) 1 (2.6) ± (39.5) 2 (5.3)

8 Table 2- Echocardiographic findings Variables All paients (n=113) Good outcomes paients (n=75) Poor outcomes paients (n=38) p value At baseline LVEF - % LVEDD- mm LVESD- mm EDST- mm AorIc annulus diameter- mm AorIc valve area cm² cm²/m² AorIc mean gradient- mm Hg AorIc peak gradient- mm Hg Moderate or severe aoric regurgitaion - no. (%) Moderate or severe mitral regurgitaion- no. (%) Leq atrial area- cm² Right ventricular dysfuncion- no. (%) Moderate or severe tricuspid regurgitaion- no. (%) Pulmonary hypertension- no. (%) spap 50 mm Hg 50.1± ± ± ± ± ± ± ± ± (19.5) 45 (39.8) 28.0± (20.4) 26 (23.0) 76 (67.3) 46 (40.7) 49.5± ± ± ± ± ± ± ± ± (24.0) 25 (33.3) 26.7±6.7 9 (12.0) 10 (13.3) 48 (64.0) 24 (32.0) 51.5± ± ± ± ± ± ± ± ± (10.5) 20 (52.6) 30± (36.8) 16 (42.1) 28 (73.6) 22 (57.9) month follow- up AorIc valve area cm² cm²/m² Moderate or severe postprocedural aoric valve regurgitaion- no. /total no.(%) 1.78± ±0.3 20/108 (18.5) 1.71± ±0.28 9/72 (12.5) 1.93± ± /36 (30.6) month follow- up AorIc valve area cm² cm²/m² Moderate or severe postprocedural aoric valve regurgitaion- no. /total no.(%) 1.82± ±0.4 19/100 (19.0) 1.79± ± /73 (16.4) 1.90± ±0.46 7/27 (25.9)

9 Analyse mul.variée (variables avec p<0.2 en analyse univariée) Table 3- Multivariate analysis Predictors of short-term poor outcomes Odds ratio CI p-value Atrial fibrillation Absence of coronary artery disease Moderate or severe pre operative mitral valve regurgitation ( 2/4) No or mild pre operative aortic valve regurgitation (<2/4) Aortic annulus diameter > 22mm Systolic pulmonary artery pressure 50 mm Hg NYHA functionnal class >

10 Conclusion «Mauvais résultats» = proporion non négligeable de paients Cardiopathie valvulaire plus évoluée avec dysfoncion diastolique marquée Importance de développer un «TAVI risk score» spécifique.

11 Merci de votre auenion

12 A 60% p=ns p< p=ns 2 1,75 B p< p< p=ns p=ns % cm² 1,5 1, mm Hg 50% 1, % Baseline Post-TAVI 1 month 6 months,5 Baseline Post-TAVI 1 month 6 months 5 Figure 2 Evolution of left ventricular ejection fraction, aortic valve area and mean transaortic gradient. Figure 2A shows the evolution of LVEF. Repeated measures ANOVA showed significant difference between the echocardiographic evaluations and a subsequent Bonferroni-Dunn test showed this difference was driven by a significant improvement of LVEF between baseline and 1 month. Figure 2B shows the evolution of both aortic valve area (red line) and mean transaortic gradient (yellow line). Repeated measures ANOVA showed significant difference between the echocardiographic evaluations and a subsequent Bonferroni- Dunn test showed a significant increase of aortic valve area and a significant decrease mean transaortic gradient between the baseline and post-tavi evaluations with sustained results thereafter.

13 100% 80% 60% Patients 40% Death Moderate or severe AR No or mild AR 20% 0% Post-TAVI 1 month 6 months Figure 3 Evolution of post-tavi aortic regurgitation during follow-up. Shown are the proportions of patients in each AR grade at the time of the echocardiographic follow-up and death from all causes.cochran s Q test, including 96 patients with complete data on aortic regurgitation degree, showed no significant difference between the post-tavi and the 6-month evaluations (p<0.58).

14 100% 80% Patients 60% 40% Death Moderate or severe MR No or mild MR 20% 0% At baseline Post- procedure 1 month 6 months Figure 4 Evolution of mitral regurgitation during follow-up. Shown are the proportions of patients in each MR grade at the time of echocardiographic follow-up and death from all causes. Cochran s Q test, including 94 patients with complete data on mitral regurgitation degree, showed significant difference between baseline and post-procedural evaluations (p<0.001) without further improvement in MR degree.

15 Gotzmann M et al. Am J Card 2012 Rodés Cabau J et al. J Am Coll Card 2012

16 Toggweiler et al. J Am Coll Card 2012

17 Tamburino et al. CirculaHon 2011 Gotzmann M et al. Am Heart J 2011

18 Rodés Cabau et al. J Am Coll Card 2012 Ussia GP et al. Eur Heart J 2012

19 Abdel- Wahab M et al. Heart 2012 Jabbour A et al. J Am Coll Card 2011 van Belle noted that predictors of aoric regurgitaion with the balloon- expandable device included the diameter of aoric annulus and diameter of the prosthesis, but these variables had no impact when a self- expandable device was used. Unpublished data. TCT 2012

20 Abdel- Wahab M et al. Clin Res Card 2012 Thomas M et al. CirculaHon 2011

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