I have the following potential conflicts of interest to report: Other(s): Proctor for Medtronic for TAVI cases using the CoreValve/Evolut R devices

Transcription

1 Transcatheter aortic valve implantation for failed surgical aortic bioprostheses using a selfexpanding 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, Rennes, France Dr. Bernard Chevalier, Institut Cardio-vasculaire Paris-Sud, Massy, France and on behalf of the VIVA Investigators

2 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 the CoreValve/Evolut R devices

3 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-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.

4 Aims The objective of the Valve In VAlve trial (VIVA) is to systematically and prospectively collect data 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.

5 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. 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 presence 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.

6 Trial Organisation Executive Committee/PIs: R. Kornowski, D. Tchétché, JP Verhoye Publication Committee: R. Kornowski, D. Tchétché, JP Verhoye, B. Chevalier CERC, Massy, France CRO: 1) CEC: P. Ménasché (Chair), G. Sardella, N. Löffelhardt 2) Echo Corelab: M. Poupineau 3) Site management Sponsor: Medtronic

7 Endpoints and Compliance Primary Safety Endpoint: Primary Efficacy Endpoint: Secondary Endpoints: 30-day Compliance: Cardiovascular death at 30 days post procedure; expected to be below 10%. Lack of significant aortic stenosis (mean gradient > 40mmHg) or insufficiency (> moderate severity) at 1 year post procedure using clinical evaluation and echocardiography VARC-II endpoints: Access site complications, major bleeding, stroke, AKI stage III, new pacemaker implantation, and postimplantation aortic gradient 98.5% (191/194)

8 Baseline Characteristics Characteristic All (N=202) Age (yrs) 79.9 ± 7.2 Men 47.0 Height (cm) ± 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 replacement therapy 1.5 Previous stroke 5.0 NYHA III/IV 70.7 LVEF % (n) Values are mean ± SD or % ± 12.0 (157)

9 Devices Utilized CoreValve Enrolled: n=19 Evolut R Enrolled: n=183

10 Mode of Bioprosthetic Failure Failure Mode Pre-procedure hemodynamics All (N=202) Stenosis (N=114) Regurgitation (N=46) Combined (N=42) AV max gradient, 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

11 Surgical Valve Types

12 Surgical Valve Characteristics Characteristic Time since last SAVR, yrs (mean ± SD) (median) Surgical valve type (%) Stented Stentless Label size (%) 21 mm > 21 mm and < 25 mm 25 mm Internal diameter (%) < 20 mm 20 mm and < 23 mm 23 mm All (N=202) 9.3 ±

13 Procedural Characteristics All Characteristic (N=202) Procedural success (%) * 98.5 Device size (%) 23-mm 26-mm 29-mm 31-mm Access (%) Ilio-femoral Subclavian/Axillary Transcarotid Direct aortic Anesthesia (%) Local General Sedation *CoreValve/Evolut R device successfully deployed into surgical aortic bioprosthesis

14 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 occurred soon after the procedure. All 4 cases occurred in Mitroflow SAVs.

15 Mortality Primary Endpoint: Cardiovascular Mortality at 30 Days 10% 9% 8% All-cause Mortality Cardiovascular Mortality 7% 6% 5% 4% 3% 2% 1% 2.5% 2.0% 0% Days After Procedure No. at risk:

16 Endpoint Other Clinical Outcomes at 30 Days 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 Acute kidney injury (%)* Stage I Stage II or III 14.9 Permanent pacemaker implantation (%) Kaplan-Meier event rates. *According to the Valve Academic Research Consortium 2 (VARC-2) definition Baseline pacemaker included

17 Mortality by logeuroscore

18 Mortality by Failure Mode

19 Mortality by Surgical Valve Type

20 Paravalvular Regurgitation

21 Echocardiographic Findings by Failure Mode

22 NYHA Classification

23 Conclusions 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 LogEuroSCORE 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 <10%). 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 favorable, 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.

24 Participating Centers France Clinique Pasteur; Toulouse - Dr. Didier Tchétché Hopital Jacques Cartier; Massy Dr. Bernard Chevalier 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. Martine 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; Bad 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