Transcatheter Aortic-Valve Replacement with a Self-Expanding

Prosthesis

David H. Adams et al(U.S. CoreValve Clinical Investigators)

Journal ClubNovember 20th Scott C Laura

TAVR with a Self-Expanding Prosthesis

• Objective– Comparison of TAVR with self expanding

bioprosthesis with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery

TAVR with a Self-Expanding Prosthesis

• Background (Dismal prognosis after symptom onset) – Often affects elderly, a population often with

increased surgical risk – TAVR improves survival compared with medical

therapy for those with increased surgical risk– TAVR similar to Surgical with respect to survival

(high risk pop) albeit higher frequency of neurological events

TAVR with a Self-Expanding Prosthesis

• Methods– Multicenter, Randomized, non-inferiority trial – Medtronic Funded, developed protocols, selected

45 clinical sites throughout US, monitored/managed all source data and statistical analyses

– Analyses for primary and secondary endpoints validated by Harvard Clinical Research Institute

TAVR with a Self-Expanding Prosthesis

• Inclusion– Severe AS and NYHA class II or higher:• Aortic valve area of ≤0.8cm2 or AV area index

≤0.5cm2/m2 AND Mean AV gradient ≥ 40mmHg or peak aortic jet velocity ≥ 4 m/s.

– Two cardiac surgeons and one interventional cardiologist estimated risk of death w/I 30days of surgery was ≥ 15% or risk of death or irreversible complications w/I 30days ≤ 50%

TAVR with a Self-Expanding Prosthesis

Population• 900 eligible patients, 871 patients

enrolled, 795 randomized• 394 TAVR -> 390 completed• 401 Surgical -> 357 completed

TAVR with a Self-Expanding Prosthesis

• Results – Primary End Point: rate of death from any cause

at 1 year TAVR 14.2% and surgical group 19.1% representing an ARR of 4.9% P<0.001 for noninferiority, P = 0.04 for superiority)

TAVR with a Self-Expanding Prosthesis

• Secondary End Points – TAVR noninferior to Surgical • Mean Aortic Valve gradient Change from baseline to

one year • Effective Orifice area change from baseline to one year• NYHA class change from baseline to one year

TAVR with a Self-Expanding Prosthesis

• Conclusions– Survival at 1 year after TAVR superior to surgery – Suggest that the occurrence of Major Adverse

Cerdiovascular and Cerebrovascular events lower in TAVR group at 1 year

– No increased risk of stroke with TAVR at 1 year

TAVR with a Self-Expanding Prosthesis

• Cautions/Future– Lower surgical risk population than previous

studies – Actual mortality rate at 30Ds amoung surgical

patients was 4.5% (much lower than the predicted rate IE greater than 15%)

– More patients declined surgery after randomization

AORTIC

Stenosis