Transcatheter - PDF document

1 Transcatheter aortic valve implantation
Transcatheter aortic valve implantation for failed surgical aortic bioprostheses using a self - expanding device: early results from the prospective VIVA post - market study Prof. Ran Kornowski , Rabin Medical Center, Petah Tikva , Israel Dr. Didier Tchétché , Clinique Pasteur, Toulouse, France Prof. Jean - Philippe Verhoye , CHU Rennes, Re

2 nnes, France Dr. Bernard Chevalier, Ins
nnes, France Dr. Bernard Chevalier, Institut Cardio - vasculaire Paris - Sud, Massy, France and on behalf of the VIVA Investigators Speaker's name: Prof. Ran Kornowski  I do not have any potential conflict of interest X I have the following potential conflicts of interest to report: • Other(s): Proctor for Medtronic for TAVI cases using t

3 he CoreValve / Evolut R devices Backgro
he CoreValve / Evolut R devices Background • Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. • However, bioprosthetic valves degenerate over time, requiring re - do surgery to replace them. • As many patients are not candidates for reoperation, a less invasive valve

4 - in - valve ( ViV ) procedure using t
- in - valve ( ViV ) procedure using transcatheter aortic valve implantation (TAVI) is an emerging alternative. • The VIVA trial was designed to create a large prospective dataset among ViV patients treated in clinical practice. Aims • The objective of the Valve In VAlve trial (VIVA) is to systematically and prospectively collect dat

5 a regarding use of TAVI with the CoreVa
a regarding use of TAVI with the CoreValve and Evolut R devices in patients with failing surgical aortic bioprostheses at high risk for re - do open - heart surgery. Methods • VIVA is an observational, single - arm, post - market multi - center study conducted at 23 sites in France, Germany, Israel, and Italy, which enrolled 202 patients

6 . • Adults with symptomatic degenerat
. • Adults with symptomatic degeneration of an aortic bioprosthesis (stenosis and/or regurgitation) who were acceptable candidates for elective treatment with a self - expanding transcatheter aortic valve were eligible for inclusion. • Patients were required to have a logistic EuroSCORE �20% or STS score �10%, or presenc

7 e of comorbidities that contraindicated
e of comorbidities that contraindicated redo surgery as assessed by the cardiologist and at least one cardiac surgeon OR deemed at high - risk for redo surgery by the heart team. Trial Organisation Executive Committee/PIs: R. Kornowski, D. Tchétché , JP Verhoye Publication Committee: R. Kornowski, D. Tchétché , JP Verhoye , B. Chevalier CRO:

8 CERC, Massy, France 1) CEC: P. Ménasc
CERC, Massy, France 1) CEC: P. Ménasché (Chair), G. Sardella , N. Löffelhardt 2) Echo Corelab : M. Poupineau 3) Site management Sponsor: Medtronic Endpoints and Compliance Primary Safety Endpoint: Primary Efficacy Endpoint: Cardiovascular death at 30 days post procedure; expected to be below 10%. Lack of significant aortic stenosis (me

9 an gradient � 40mmHg) or insu
an gradient � 40mmHg) or insufficiency �( moderate severity) at 1 year post procedure using clinical evaluation and echocardiography Secondary Endpoints: VARC - II endpoints: Access site complications, major bleeding, stroke, AKI stage III, new pacemaker implantation, and post - implantation aortic gradient 30 - day Compli

10 ance: 98.5% (191/194) Baseline Characte
ance: 98.5% (191/194) Baseline Characteristics Characteristic All ( N= 202 ) Age ( yrs ) 79.9 ± 7.2 Men 47.0 Height ( cm) 164.3 ± 9.1 Weight ( kg) 73.7 ± 16.3 BMI ( kg/ m 2 ) 27.2 ± 5.4 BSA ( m 2 ) 1.8 ± 0.2 LogEuroSCORE (%) 25.0 ± 14.3 STS score (%) 6.6 ± 5.1 Diabetes mellitus 26.2 Peripheral vascular disease 13.9 Chronic renal replacem

11 ent therapy 1.5 Previous stroke 5.0 NYHA
ent therapy 1.5 Previous stroke 5.0 NYHA III/ IV 70.7 LVEF % ( n) 61.0 ± 12.0 (157) Values are mean ± SD or %. Devices Utilized CoreValve Enrolled: n=19 Evolut R Enrolled: n= 183 Mode of Bioprosthetic Failure Failure Mode Pre - procedure hemodynamics All ( N= 202 ) Stenosis ( N= 114 ) Regurgitation ( N= 46 ) Combined ( N= 42 ) AV max gradient,

12 mmHg (mean ± SD)* (n) 56.0 ± 30.5 (1
mmHg (mean ± SD)* (n) 56.0 ± 30.5 (115) 67.0 ± 28.8 (71) 32.9 ± 25.1 (28) 47.4 ± 20.8 (16) AV mean gradient, mmHg (mean ± SD) (n) 31.6 ± 15.2 (162) 35.2 ± 14.0 (99) 19.9 ± 11.5 (32) 31.8 ± 16.5 (31) AV regurgitation ≥ +2 (%)* (n) 52.1 (142) 22.4 (76) 88.6 (35) 83.9 (31) *site - reported data; core lab data pending Surgical Valve Ty

13 pes Surgical Valve Characteristics Char
pes Surgical Valve Characteristics Characteristic All (N=202) Time since last SAVR, yrs (mean ± SD) (median) 9.3 ± 4.4 8.8 Surgical valve t ype (%) Stented Stentless 93.1 6.9 Label size (%) ≤ 21 mm � 21 mm and 25 mm ≥ 25 mm 41.3 32.8 25.9 Internal diameter (%) 20 mm ≥ 20 mm and < 23 mm ≥ 23 mm 40.9 35.1 24.0 Procedural Characte

14 ristics Characteristic All ( N= 202 ) Pr
ristics Characteristic All ( N= 202 ) Procedural success (%) * 98.5 Device size (%) 23 - mm 26 - mm 29 - mm 31 - mm 63.7 26.9 9.5 0.0 Access (%) Ilio - femoral Subclavian/Axillary Transcarotid Direct aortic 96.5 2.0 1.0 0.5 Anesthesia (%) Local General Sedation 41.6 23.3 35.1 * CoreValve / Evolut R device successfully deployed into surgical aorti

15 c bioprosthesis Procedural Characterist
c bioprosthesis Procedural Characteristics Characteristic All ( N= 202 ) Pre - implantation valvuloplasty (%) 13.9 Device retrieved (%) 2.0 Post - implantation valvuloplasty (%) 20.8 Second device implantation (%) 2.5 Coronary obstruction (%)* 2.0 Converted to surgical AVR (%) 0.5 * 3 cases intra - procedural and 1 additional obstruction occur

16 red soon after the procedure. All 4 case
red soon after the procedure. All 4 cases occurred in Mitroflow SAVs. Primary Endpoint : Cardiovascular Mortality at 30 Days No. at risk: 202 180 2.5% 2.0 % 0% 1% 2% 3% 4% 5% 6% 7% 8% 9% 10% 0 5 10 15 20 25 30 Mortality

17 Days After Procedure All-cause Mortality
Days After Procedure All-cause Mortality Cardiovascular Mortality Other Clinical Outcomes at 30 Days Endpoint All ( N= 202 ) Duration of hospital stay, days (mean ± SD) 7.4 ± 6.1 All stroke (%) 3.0 Disabling (%) 0.0 Major vascular complication (%)* 6.5 Bleeding (%)* Life - threatening Major Minor 14.9 0.0 7.0 7.9 Acute kidney injury (%)* Stage

18 I Stage II or III 0.5 0.5 0.0 Permanent
I Stage II or III 0.5 0.5 0.0 Permanent pacemaker implantation (%) £ 7.0 Kaplan - Meier event rates. *According to the Valve Academic Research Consortium 2 (VARC - 2 ) definition £ Baseline pacemaker included Mortality by logEuroSCORE Mortality by Failure Mode Mortality by Surgical Valve Type Paravalvular Regurgitation Echocardiographic Find

19 ings by Failure Mode NYHA Classificatio
ings by Failure Mode NYHA Classification • The VIVA trial confirmed the feasibility, safety and effectiveness of the TAVI ViV intervention using the CoreValve / Evolut R devices in high - risk patients with failing surgical aortic bioprostheses . • 30 - day mortality/CV mortality was 2.5%/2.0% among patients who had average LogEuroSCO

20 RE 25% and mean STS 6.6%. In this respec
RE 25% and mean STS 6.6%. In this respect, the study met its primary safety endpoint at 30 - days (which was pre - defined as 30 - day CV mortality rate 0%). • Complications were mostly minor (i.e. not life threatening) and at a relatively low rate. • Echocardiography data at discharge and NYHA functional class after 30 - days are favorab

21 le, which indicates the short - term eff
le, which indicates the short - term effectiveness of this mode of treatment. • The one - year clinical and echocardiographic efficacy data are awaited and will be reported in the near - future. Conclusions Participating Centers France Clinique Pasteur; Toulouse - Dr. Didier Tchétché Hopital Jacques Cartier; Massy – Dr. Bernard Chevali

22 er CHU Mondor ; Créteil - Prof. Emmanu
er CHU Mondor ; Créteil - Prof. Emmanuel Teiger CHU de Nantes - Dr. Thibaut Manigold CHU Lille – Dr. Thomas Modine CHU Clermont; Clermont - Ferrand – Dr. Geraud Souteyrand Tonkin Clinic; Villeurbanne – Dr. Didier Champagnac CHU Rennes - Prof. Jean Philippe Verhoye CHU Bordeaux; Pessac - Dr Lionel Leroux CHU Brest - Prof. Marti

23 ne Gilard CHU Rangueil ; Toulouse - D
ne Gilard CHU Rangueil ; Toulouse - Dr. Bertrand Marcheix Clinique Parly 2; Le Chesnay - Dr. Gregoire Dambrin CHU La Timone ; Marseille - Dr. Dominique Grisoli Germany Herzzentrum Leipzig - Dr. David Holzhey Sana - Herzzentrum Cottbus - Dr. Axel Harnath UK Hamburg Eppendorf - Prof. Ulrich Schäfer Herz - und Diabeteszentrum NRW; B

24 ad Oeynhausen - Dr. Werner Scholtz Ker
ad Oeynhausen - Dr. Werner Scholtz Kerckhoff Klinik ; Bad Nauheim - Dr. Won - Keun Kim Israel Rabin Medical Center; Petah Tikva - Prof. Ran Kornowski Sheba Medical Center; Tel Hashomer - Prof. Victor Guetta Italy Brescia Hospital - Dr. Federica Ettori Pisa Hospital - Prof. Anna Sonia Petronio San Donato; Milano - Prof. Francesco Bedogni