Conclusions Systematic identification of new-onset arrhythmias following TAVI may have considerable impact on subsequent therapeutic management and long-term prognosis in this patient population
Objective To evaluate the prevalence and clinical impact of new-onset arrhythmias in patients following transcatheter aortic valve implantation ( TAVI ) .
1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial.
BACKGROUND The use of a balloon-exp and able transcatheter heart valve previously result ed in a greater rate of device success compared with a self-exp and able transcatheter heart valve . OBJECTIVES The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up . METHODS The investigator-initiated trial r and omized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon- and self-exp and able transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device .  Patients were followed-up for 1 year , with assessment of clinical outcomes and echocardiographic evaluation of valve function . RESULTS At 1 year , the rates of death of any cause ( 17.4 % vs. 12.8 % ; relative risk [ RR ] : 1.35 ; 95 % confidence interval [ CI ] : 0.73 to 2.50 ; p = 0.37 ) and of cardiovascular causes ( 12.4 % vs. 9.4 % ; RR : 1.32 ; 95 % CI : 0.63 to 2.75 ; p = 0.54 ) were not statistically significantly different in the balloon- and self-exp and able groups , respectively . The frequencies of all strokes ( 9.1 % vs. 3.4 % ; RR : 2.66 ; 95 % CI : 0.87 to 8.12 ; p = 0.11 ) and repeat hospitalization for heart failure ( 7.4 % vs. 12.8 % ; RR : 0.58 ; 95 % CI : 0.26 to 1.27 ; p = 0.19 ) did not statistically significantly differ between the 2 groups . Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-exp and able group ( 3.4 % vs. 0 % ; p = 0.12 ) ; all were resolved with anticoagulant therapy , suggesting a thrombotic etiology . More than mild paravalvular regurgitation was more frequent in the self-exp and able group ( 1.1 % vs. 12.1 % ; p = 0.005 ) . CONCLUSIONS Despite the higher device success rate with the balloon-exp and able valve , 1-year follow-up of patients in CHOICE ( R and omized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis : Medtronic CoreValve Versus Edwards SAPIEN XT Trial ) , with limited statistical power , revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon- and self-exp and able prostheses that were not statistically significantly different . ( A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis : The CHOICE Trial ; NCT01645202 )
Conclusions Systematic identification of new-onset arrhythmias following TAVI may have considerable impact on subsequent therapeutic management and long-term prognosis in this patient population
Objective To evaluate the prevalence and clinical impact of new-onset arrhythmias in patients following transcatheter aortic valve implantation ( TAVI ) .