Balloon-Expandable Transcatheter Valve System : OUS Data

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Balloon-Expandable Transcatheter Valve System : OUS Data Alec Vahanian, FESC, FRCP Bichat Hospital, Paris Put the title of french society of cardiology ,see with stephanie

Alec Vahanian, MD Honoraria: Valtech Edwards Lifesciences Medtronic, Abbott

Cardiogenic shock, patient not amenable to surgical treatment TAVI First in man Cardiogenic shock, patient not amenable to surgical treatment Alain Cribier, 16 April 2002 4 4

Major vascular access complications Source Registry 2307 TAVI procedures (2009) in 37 centers Edwards Sapien TF (n=920) TA (n=1387) P-value Age(yr) 82±7 81±7 <0.001 LogEuroscore(%) 23.9±14.2 27.6±16 Procedural success 93 92.2 ns New pacemaker 6.7 7.1 Stroke 2.9 2.5 Major vascular access complications 11.3 2.0% (Thomas M et al Circulation 2011;124:425-33)

Source Registry 1-YEAR SURVIVAL 95% 90% 85% 80% 75% 70% All TF TA 100% 95% 90% 85% 80% 75% 70% All(N=2307) Transfemoral(N=920) Transapical(N=1387) Survival 65% 60% 55% Survival 30 Days 1 Year All 90.5% 76.5% TF 92.5% 80.1% TA 89.1% 74.2% 50% 3 6 9 12 15 18 21 24 Time to Death (Months) 9 (Thomas M et al Circulation 2011;124:425-33)

European TAVI Registries French registry 33 centers, 4042 consecutive pts Belgian registry 18 centers, 600 consecutive pts United Kingdom registry 26 centers 872 consecutive pts German registry 22 centers 833 consecutive pts Italian registry 14 centres 663 pts CoreValve

On behalf of the scientific committee and the investigators FRANCE 2 : FRench Aortic National Corevalve and Edwards Registry Martine Gilard and Marc Laskar On behalf of the scientific committee and the investigators P Donzeau-Gouge, K Chevreul, H Eltchaninoff, J Fajadet, B Iung, P Leprince, A Leguerrier, M Lievre, A Prat, E Teiger ESC 2011 - Paris

FRANCE Registry All centers selected by the Ministry of Health Registry co-ordinated by the French Societies of Cardiology and Cardiac Surgery Two models of THV used: Edwards Sapien (transfemoral and transapical approaches) and CoreValve (transfemoral and subclavian approaches) Training and proctoring completed in all centers

FRANCE 2 Current enrollment 9 January 2012: 4 042pts Inclusion / month 2010 = 132 Inclusion / month 2011 = 190

FRANCE 2 Interim analysis 3195 consecutive patients- 34 centres January 1, 2010 to October, 2011

FRANCE 2 Methods Clinical prospective and comprehensive registry All events and values site recorded No core lab Patients followed up to 3 years by serial clinical and echo assessments and 5 years by clinical status 30 d 6 mos 1 yr 2 yrs 3 yrs 4 yrs 5 yrs

Inclusion criteria and Endpoints FRANCE 2 Inclusion criteria and Endpoints Inclusion criteria: All implanted patients 1- Severe aortic stenosis: E.O.A. < 0.6cm²/m² 2- Severe symptoms: dyspnea NYHA > 2 3- Patient at high surgical risk (Log. EuroScore > 20%, STS > 10% or C-I to surgery) Primary Endpoint: 30 day mortality, 6 month mortality, up to 5-y Secondary Endpoints (up to 5-y): M.A.C.E., hemodynamics, Q.O.L.

Valves and approaches used FRANCE 2 Valves and approaches used Valves Approach TA TF SC (5%) (29%) (66%)

FRANCE 2 Baseline Demographics and Risk Factors Age, y 82.7 ±7 Female, % 49.0 % Previous MI, % 16.4 % CAD, % 48 % Previous CABG, % 18.2% PAD, % 20.8% Previous Stroke, % 10.0% Dialysis, % 2.7% Previous AVR 1.6% Smoker, % 2,8 % Hypertension, % 69.4 % Diabetes, % 25.8 % Dyslipidimia, % 48 %

FRANCE 2 Risk scores NYHA functional class L. Euroscore, % 21.9 ± 14 STS, % 14.4 ± 12 (26%) (16%) NYHA functional class I - II III - IV 25% 75 %

FRANCE 2 Baseline echocardiographic data Ao annulus (mm) 22.1 ± 2.1 Gradient (mm Hg) 48.1 ± 16.6 AVA (cm²) 0.7 ± 0.2 SPAP (mm Hg) 46.5 ± 15 Ejection fraction (%) 53.2 ± 14.1

FRANCE 2 Procedural characteristics (84%) 74.7% 15.3% 9.9% (21%) (12%) General anesthesia, % 59 % Per-procedure TEE, % 60.7 % (84%) 74.7% (67%) Operative room Cath-lab Hybrid room

FRANCE 2 Implantation Success Device success rate: 96.9% TF TA SC 97.1 95.9 96.7 Definition: successful delivery and deployment of the valve

FRANCE 2 KM Mortality rate 30-day 6-month Total 293 9.7 % 474 18.6 % 528 24.0 %

FRANCE 2 KM Mortality rate Type of Valve 30-day 12-month Edwards 195 9.6% 352 24.0% CoreValve 91 9.4% 168 23.7% Edwards CoreValve L. Euroscore 22.2 ± 14.3 21.3 ± 14,3

FRANCE 2 KM Mortality rate Access Mortality TF Edwards TF CoreValve TA Edwards n=561 SC CoreValve n=180 30-day 8.1% 9.3% 13.9% 10.1% 6-month 16.4% 18.8% 22.4% 22.7% 12month 20.7% 23.3% 32.3% 24.6%

Vascular complications Bleeding(+tamponade) FRANCE 2 Major complications (30 days) Total N = 3195 Edwards N= 2107 CoreValve N=1043 Vascular complications 9.7% 10.7% 9.2% New Pacemaker 15.6 11.5% 24.2% Bleeding(+tamponade) 13.1% 11.4% 8.8% Stroke 4.1% 3.8% 4.3%

Hemodynamics after implantation FRANCE 2 Hemodynamics after implantation Effective Valve Area (cm²) Mean gradient (mmHg)

Aortic regurgitation (grade) FRANCE 2 Aortic regurgitation (grade) Grade 0-1 Grade 2 Grade 3 Central Peri-prothethic

Functional Status (NYHA) FRANCE 2 Functional Status (NYHA)

Predictive factors of 30-day, 6-month 1-year mortality FRANCE 2 Predictive factors of 30-day, 6-month 1-year mortality Over 20 risk factors were analyzed Logistic Euroscore, NYHA functional class and TA approach were the only predictors of 30-day, 6-month and 1 year mortality by multivariate analysis

Procedural success (%) Belgian TAVI Registry Edwards (n=303) CoreValve (n=297) Total population (n=600) P-value Age(yr) 83±6 ns LVEF(%) 50±15 57±15 53±15 LogEuroscore(%) 29±15 24±15 26±16 Procedural success (%) 97 99 98 ns New pacemaker(%) 4 23 14 0.0001 Stroke(%) 5 1-month Survival(%) 92 93 (Bosmans et al Inter Cardiovasc Thoracic Surgery 2011;12:762-67)

(Blackman. PCR London Valve Oct 2011.) Outcomes in UK registry with different valves and access routes Outcome Edwards transfemoral, n=389 (%) CoreValve transfemoral, n=706 p Edwards transapical, n=409 CoreValve subclav., n=91 30-d mortality 4.3 5.2 NS 11.2 4.4 12-mo survival 84.5 80.8 0.453 74.5 75.4 New permanent pacemaker 6.2 21.6 <0.001 5.6 22.1 Aortic regurg. ≥ 2/4 8.4 13.4 0.015 6.4 9.5 (Blackman. PCR London Valve Oct 2011.)

Conclusions The current European registries included over 5000 patients They confirm the safety and efficacy of the Balloon expandable transcatheter valve systems Improvements are expected due to better patient selection,management of the procedure and technology…..