TAVI: Nouveaux Horizons
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1 TAVI: Nouveaux Horizons EUAPI580i 432HQ14NP02353 Institut de Cardiologie de la Pitié-Salpêtrière
2 Objectifs Les recommandations Le TAVI en chiffre La technique La sélection des patients Les résultats Le traitement antithrombotique Durabilité Situations particulières
3 ESC/EACTS Guidelines Class I: Inoperable Heart Team required On-site cardiac surgery Class IIa: High-risk for surgery. Heart team decides. EUAPI580i 432HQ14NP02353
4 Objectives Les recommandations Le TAVI en chiffre La technique La sélection des patients Les résultats Le traitement antithrombotique Durabilité Situations particulières
5 Cumulative implants in Europe
6 Germany :TAVI a Game Changer in AVR EUAPI580i 432HQ14NP02353 % Patients undergoing conventional AVR vs TAVI
7 Worldwide TAVI distribution Rest of the World 11% 28% United States Western Europe 61% Courtesy of BIBA Medtech
8 600 Projected TAVR Heart Teams By Region EU EEMEA China/HK APAC Japan LAM USA Canada Highly dependent on reimbursement, continued procedural success.
9 Objectifs Les recommandations Le TAVI en chiffre La technique La sélection des patients Les résultats Le traitement antithrombotique Durabilité Situations particulières
10 Trends in TAVI. France N= Age(yr) 82±7 83±7 83±9 84±9 LES (%) 23±14 21±14 19±13 17±12 General Anesthesia (%) Hybrid Room (%) TA (%) Transfemoral (%) Length of stay (d)
11 France TAVI day Results 41 centres 64% of 3707 TAVI Success rate: 94.1% Death (%) 6.6 Annulus Rupture(%) 0.4 Valve migration(%) 1.3 Coronary obstruction(%) 0.4 Tamponade(%) 1.2 Surgery(%) 0.6 Stroke with sequelae (%) 2 Vascular complication(%) 6.6 Pacemaker (%) Edw: 8.1/ MCV: 21 Bataille et al.
12 FRANCE 2-France TAVI France 2 France-TAVI SAPIENS COREVALVE AUTRES 0 3
13 EUAPI580i 432HQ14NP02353
14 Edwards SAPIEN 3 Valve Edwards CENTERA Valve Balloon Expandable Designed to further reduce PV leaks. TF delivery through a 14 Fr esheath. Dramatically reduced TA profile: 18 F. Discrete valve anchors in the annulus. Edwards bovine pericardial tissue leaflets. CE Approved Self Expanding Motorized delivery system for stable deployment and single operator use. Repositionable & pre-loaded. Delivered through a 14 Fr esheath. Discrete valve anchors in the annulus. Edwards bovine pericardial tissue leaflets. Binder et al. JACC Interv 2013;6:301
15 Drawn to scale. Not actual French sizes. Corevalve Evolute R
16 Corevalve Evolute R
17 Objectifs Les recommandations Le TAVI en chiffre La technique La sélection des patients Les résultats Le traitement antithrombotique Durabilité Situations particulières
18 A shift to lower risk ,8 20,9 19,2 17,
19 Risk scores STS-PROM >10% and Euroscore>20% Standard surgical risk populations/short-term outcome Euroscore II : better discrimination (NYHA, diabetes, impaired mobility) Lack of specific risk factors (porcelaine aorta, frailty, vessel tortuosity) should be based on standardized definitions (VARC) Eur Heart J Oct 7;35(38):
20 The near future How to improve discrimination between low- and high-surgical risk (including SAVR)? How to identify patients who should be referred for TAVI? How to predict procedural risk and outcome in TAVI candidates. Eur Heart J Oct 7;35(38):
21 Objectifs Les recommandations Le TAVI en chiffre La technique La sélection des patients Les résultats Le traitement antithrombotique Durabilité Situations particulières
22 Death from any cause (%) Mortality after aortic valve replacement No at risk: TAVR Surgical replacement Surgical replacement TAVR Months p=0.04 for superiority Adams DH et al. N Engl J Med 2014;370:1790 8
23 All stroke (%) All stroke after aortic valve replacement 20 Surgical Transcatheter % % 5 6.2% 4.9% Log-rank P=0.10 Number at risk Months post-procedure Adams DH et al. N Engl J Med 2014;370:1790 8
24 Death Incidence (%) Mortality and STS Score (ITT) (Partner) (Society Thoracic Surgery Score) Standard Rx TAVR 100% STS <5 100% STS % STS 15 80% 80% 80% 60% 60% 60% 40% 40% 40% 20% 20% 20% 0% % % Months Months Months Numbers at Risk
25 Long Term Outcomes of TAVI 339 patients, 52% TA, 3.5 years median f/u 17.8% Unknown 23% Cardiac CHF 15.1% Sudden Death 2.6% MI 3.9% Endocarditis 0.7% MVR 0.7% 59.2% Non Cardiac Pulmonary 26.9% Kidney Failure 7.9% Stroke 5.9% Major Bleeding 4.6% Cancer 5.3% Other 8.6% Rodes-Cabau et al. JACC 2012;60:
26 Inoperable Patients, Partner 1B. Makkar et al. JACC 2014;63: Standard Therapy Clin. Inoperable Techn. Inoperable
27 Objectifs Les recommandations Le TAVI en chiffre La technique La sélection des patients Les résultats Le traitement antithrombotique Durabilité Situations particulières
28 % patients Pattern of use of antithrombotic therapy following TAVI consecutive patients with symptomatic severe aortic stenosis who underwent TAVI 40,6 54, ,3 25, ,6 15,4 10,5 8,5 8,4 5,5 6,3 4,1 1,2 1,8 3,7 1,2 Baseline Discharge 30 day None Single antiplatelet therapy Dual antiplatelet therapy Oral anticoagulant Antiplatelet + oral anticoagulant Triple therapy Nombela-Franco L et al. Circulation 2012;126:
29 Objectifs Les recommandations Le TAVI en chiffre La technique La sélection des patients Les résultats Le traitement antithrombotique Durabilité Situations particulières
30 Durability Gurvitch et al Circulation 2010
31 Durability Gurvitch et al Circulation 2010
32 Objectives Les recommandations Le TAVI en chiffre La technique La sélection des patients Les résultats Le traitement antithrombotique Durabilité Situations particulières
33 PVL moderate to severe Circulation. 2014;129:
34 CAD and TAVR Half of patients eligible for TAVR display significant CAD No significant impact on prognosis Severity of CAD has an impact (Syntax >22) A complete revascularization is not mandatory Optimal of revascularization timing unknown
35 Conclusions Value of 3D imaging for prothesis sizing Assessement of complex valve anatomy/disease Concomittant MR/CAD Selection of access site/patients Predictors of PVL and of conduction disturbance Durability and long-term outcome Lower risk? Pure aortic regurgitation? Valve in valve
36 Multiple Options for Vascular Access carotid direct aortic subclavian/ axillary Transeptal IVC to Aorta Entry transapical Common Iliac RPA transfemoral
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