REBOOT trial randomized comparison of repostionable and balloonexpandable
REBOOT trial randomized comparison of repostionable and balloonexpandable bioprosthesis in patients undergoing TAVI Julinda Mehilli, MD, FESC Klinikum der Universtität Ludwig-Maximilians University Munich, Germany
Potential conflicts of interest Speaker's name : Julinda, Mehilli, Munich ☑ I have the following potential conflicts of interest to report: lecture fees: Abbott, Biotronik, BMS, Boston Scientific, DAIICHI SANKYO and ELI-LILLY, Edwards Lifesciences, Terumo Receipt of grants / research supports: Abbott, Edwards Lifesciences
Background Balloon-expandable valve, SAPIEN 3 AVD 19 mm -28 mm Mechanically expanding valve, Lotus AVD 19 mm -25 mm Both designed to reduce PVL MEV the only fully retrievable prosthesis after deployment
Interaction PVL and Pacemaker Need after TAVI Meta-Analysis new pacemaker implantation van Rosendael et al. , Eur Heart J 2018
REBOOT Study Endpoints Primary endpoint 1. need for permanent pacemaker implantation within 30 days after TAVI Secondary endpoints (according to VARC-2) 1. incidence of any implant-related new disturbances or worsened cardiac conduction 2. incidence of any prosthesis regurgitation at discharge 3. combined device efficacy 4. major adverse cardiovascular and cerebrovascular events 5. incidence of vascular and bleeding complications 6. early device safety 7. peri-TAVI mortality (≤ 72 h) 8. cardiac mortality
REBOOT Decision Making Tree Pacemaker Implantation after TAVI Post-TAVI ECG changes new atrio-ventricular block I° plus previous LBBB new LBBB plus previous RBBB atrio-ventricular block II°, III° sinoatrial block atrial fibrillation with bradycardia alternating bundle branch block PQ duration >300 ms plus bradycardia* or pause >3 s transient or stable persistent (<72 h post-TAVI) progressive: QRS duration >130 ms or increasing (<48 h post-TAVI) yes no plus bradycardia* or pause >3 s or relevant atrioventricular block I° yes further 48 h monitoring post-TAVI Pacemaker Implantation * clinically-relevant; LBBB = left bundle branch block; RBB = right bundle branch block no
REBOOT study Design Study hypothesis 240 patients planed to be enroll BEV, SAPIEN 3 is superior to MEV Lotus prosthesis regarding the need for pacemaker at 30 days post-TAVI Sample size calculation assumptions PMI rate: MEV 28. 6% (REPRISE I study) & BEV 12. 4% (EVERYTAVI registry) 2 -sided α-level of 0. 05 and a power of 80 % # calculated 110/arm Participating centers Klinikum der Universität LMU München Bad Segeberger Kliniken – Herzzentrum, Bad Segeberg Azienda Ospedaliero Universitaria Pisana, Pisa 02/2017 premature termination due to MEV recall 116 pacemaker-naive patients trans-femoral TAVI 1: 1 randomization assigend to BEV n=59 assigend to MEV n=57 6 BEV 1 MEV Steering Committe Prof. S. Massberg (chair) Prof. J Mehilli (PI) Prof. G Richardt Prof. F-J Neumann Prof. C. Hagl received MEV n=52 received BEV n=64 100% of patients 30 -day and 1 -year clinical FU
REBOOT Population Key baseline characteristics Enrollment criteria MEV n=57 BEV n=59 p Age, yrs 80. 8± 5. 7 81. 2± 6. 9 0. 53 Women, % 75. 4 67. 8 0. 41 STS score 5. 0± 4. 4 4. 6± 3. 3 0. 67 Diabetes, % 21. 1 22. 0 0. 90 CKD, % 49. 1 44. 1 0. 71 Atr. fibrillation, % 24. 6 25. 4 0. 91 AVA area, mm 2 425. 3± 64. 0 426. 0± 57. 7 0. 77 Sheath size, mm 20. 4± 2. 5 14. 2± 0. 9 <0. 001 Inclusion criteria symptomatic aortic valve disease indication for valve replacement and deemed suitable for trans-femoral TAVI pacemaker-naïve native aortic valve annulus size and morphology unsuitable for both devices written informed consent Exclusion criteria hemodynamic instability or LVEF <30% concomitant severe mitral valve disease intra-cardiac mass or history of endocarditis presence of dementia or comorbidities leading to life expectancy <12 months Prosthesis size, % <0. 001 <27 mm 75. 4 96. 7 ≥ 27 mm 24. 6 3. 4 % Oversizing AVA 16. 4± 10. 8 12. 9± 11. 0 0. 06 Conversion, % 1. 7 0. 67
REBOOT Primary Endpoint Pacemaker Need 30 -Day Post-TAVI as-treat analysis intention-to-treat analysis 50 50 50. 0% 47. 4% 40 cumulative incidence 40 30 20 18. 6% 10 20 18. 8% 10 MEV BEV 0 0 5 10 15 59 57 0 20 25 30 days after TAVI Number at risk BEV MEV 30 0 5 10 15 ME V BEV 20 25 30 days after TAVI Number at risk 47 30 46 30 43 29 BEV MEV 64 52 51 26 50 26 47 25
REBOOT Secondary Endpoint Any Paravalvular Leak MEV Intention-To-Treat Analysis p=0. 01 BEV As-Treated Analysis p<0. 01 p=0. 25 p=0. 02 46. 9 50 50 42. 3 % 40 31. 5 30 25. 4 25 25. 0 20 20 10 30 7. 0 10 5. 7 0 0 Post-TAVI angio At discharge Post-TAVI echo * PVL >1 in 1 BEV-treated patient angio At discharge echo
REBOOT Secondary Endpoints 30 -Day and 1 -Year Follow-Up 30 -day follow-up 1 -year follow-up 50 50 % p=0. 95 p=0. 72 % 40 40 30 30 p=0. 96 p=0. 59 p=0. 95 p=0. 67 26, 3 22 20 20 14, 0 10 8, 8 10, 2 6, 8 10 5, 2 6, 8 8, 8 10, 2 5, 2 1, 7 0 0 Major Vascular complications Stroke LTH or Major Bleeds MEV BEV Clinical valve thrombosis MACCE Combined efficacy
1 -Year Mortality and Valve Type 50 MEV BEV cumulative incidence % 40 30 Hazard Ratio, 1. 03, 95% CI 0. 38 – 2. 74 Log-Rank P=0. 95 20 14. 0% 13. 6% 10 0 0 60 120 180 240 300 360 days
1 -Year Mortality and Pacemaker Need 50 with PM without PM cumulative incidence % 40 30 Hazard Ratio, 1. 28, 95% CI 0. 47 – 3. 51 Log-Rank P=0. 63 20 17. 8% 13. 9% 10 0 0 60 120 180 240 300 360 days
REBOOT Study proved superiority of BEV, SAPIEN 3 prosthesis over MEV, Lotus prosthesis regarding need for pacemaker after TAVI demonstrated significantly better sealing properties with MEV, Lotus prosthesis compared to BEV, SAPIEN 3 prosthesis demonstrated comparable safety and efficacy with both prosthesis platform within the first year after TAVI neither prosthesis type nor pacemaker implantation had an impact on mortality one year after TAVI
Questions and Comments: Julinda Mehilli, MD, FESC julinda. mehilli@med. uni-muenchen. de
- Slides: 15