***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: IMPORTANCE Transcatheter aortic valve replacement ( TAVR ) is an effective treatment option for high-risk patients with severe aortic stenosis . Different from surgery , transcatheter deployment of valves requires either a balloon-exp and able or self-exp and able system . A r and omized comparison of these 2 systems has not been performed . OBJECTIVE To determine whether the balloon-exp and able device is associated with a better success rate than the self-exp and able device . DESIGN , SETTING , AND PATIENTS The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure . One hundred twenty-one patients were r and omly assigned to receive a balloon-exp and able valve ( Edwards Sapien XT ) and 120 were assigned to receive a self-exp and able valve ( Medtronic CoreValve ) . Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany . INTERVENTIONS Transfemoral TAVR with a balloon-exp and able or self-exp and able device . MAIN OUTCOMES AND MEASURES The primary end point was device success , which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system , correct position of the device , intended performance of the heart valve without moderate or severe regurgitation , and only 1 valve implanted in the proper anatomical location . Secondary end points included cardiovascular mortality , bleeding and vascular complications , postprocedural pacemaker placement , and a combined safety end point at 30 days , including all-cause mortality , major stroke , and other serious complications . RESULTS Device success occurred in 116 of 121 patients ( 95.9 % ) in the balloon-exp and able valve group and 93 of 120 patients ( 77.5 % ) in the self-exp and able valve group ( relative risk [ RR ] , 1.24 , 95 % CI , 1.12 - 1.37 , P < .001 ) . This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation ( 4.1 % vs 18.3 % ; RR , 0.23 ; 95 % CI , 0.09 - 0.58 ; P < .001 ) and the less frequent need for implanting more than 1 valve ( 0.8 % vs 5.8 % , P = .03 ) in the balloon-exp and able valve group . Cardiovascular mortality at 30 days was 4.1 % in the balloon-exp and able valve group and 4.3 % in the self-exp and able valve group ( RR , 0.97 ; 95 % CI , 0.29 - 3.25 ; P = .99 ) . Bleeding and vascular complications were not significantly different , and the combined safety end point occurred in 18.2 % of those in the balloon-exp and able valve group and 23.1 % of the self-exp and able valve group ( RR , 0.79 ; 95 % CI , 0.48 - 1.30 ; P = .42 ) . Placement of a new permanent pacemaker was less frequent in the balloon-exp and able valve group ( 17.3 % vs 37.6 % , P = .001 ) . CONCLUSIONS AND RELEVANCE Among patients with high-risk aortic stenosis undergoing TAVR , the use of a balloon-exp and able valve result ed in a greater rate of device success than use of a self-exp and able valve . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01645202 BACKGROUND Transcatheter aortic valve replacement ( TAVR ) is an option in certain high-risk surgical patients with severe aortic valve stenosis . It is unknown whether TAVR can be safely introduced to lower-risk patients . OBJECTIVES The NOTION ( Nordic Aortic Valve Intervention Trial ) r and omized clinical trial compared TAVR with surgical aortic valve replacement ( SAVR ) in an all-comers patient cohort . METHODS Patients ≥ 70 years old with severe aortic valve stenosis and no significant coronary artery disease were r and omized 1:1 to TAVR using a self-exp and ing bioprosthesis versus SAVR . The primary outcome was the composite rate of death from any cause , stroke , or myocardial infa rct ion ( MI ) at 1 year . RESULTS A total of 280 patients were r and omized at 3 Nordic centers . Mean age was 79.1 years , and 81.8 % were considered low-risk patients . In the intention-to-treat population , no significant difference in the primary endpoint was found ( 13.1 % vs. 16.3 % ; p = 0.43 for superiority ) . The result did not change in the as-treated population . No difference in the rate of cardiovascular death or prosthesis reintervention was found . Compared with SAVR-treated patients , TAVR-treated patients had more conduction abnormalities requiring pacemaker implantation , larger improvement in effective orifice area , more total aortic valve regurgitation , and higher New York Heart Association functional class at 1 year . SAVR-treated patients had more major or life-threatening bleeding , cardiogenic shock , acute kidney injury ( stage II or III ) , and new-onset or worsening atrial fibrillation at 30 days than did TAVR-treated patients . CONCLUSIONS In the NOTION trial , no significant difference between TAVR and SAVR was found for the composite rate of death from any cause , stroke , or MI after 1 year . ( Nordic Aortic Valve Intervention Trial [ NOTION ] ; NCT01057173 ) Objective Women with severe aortic valve stenosis ( AS ) have better LV systolic function and more concentric LV geometry than their male counterparts . However , sex differences in cardiovascular ( CV ) outcome during progression of AS have not been reported from a longitudinal prospect i ve study . Methods Doppler echocardiography and CV events were recorded during a median of 4.0 years in 979 men and 632 women aged 28–86 ( mean 67±10 ) years in the Simvastatin Ezetimibe in Aortic Stenosis ( SEAS ) study . LV systolic function was assessed by EF and midwall shortening ( MWS ) . Study outcomes were AS-related events , ischaemic CV events and total mortality . Results The annular cumulative incidence of AS events , ischaemic CV events and death was 8.1 % , 3.4 % and 2.8 % in women , and 8.9 % , 4.4 % and 2.4 % in men , respectively . Women and men had similar AS progression rate whether measured by peak jet velocity , mean gradient or valve area . In multivariate analyses , female sex independently predicted less reduction in LV MWS and EF during follow-up ( both p<0.05 ) . In time-varying Cox analyses , women had a 40 % lower rate of ischaemic CV events ( 95 % CI 21 % to 54 % ) , in particular , more than 50 % lower rate of stroke and coronary artery bypass grafting , and a 31 % lower all-cause mortality ( 95 % CI 1 % to 51 % ) , independent of active study treatment , age and hypertension , as well as time-varying valve area , low systolic function and abnormal LV geometry . AS event rate did not differ by sex . Conclusions In the SEAS study , women and men had similar rates of AS progression and AS-related events . However , women had lower total mortality and ischaemic CV event rate than men independent of confounders . Trial registration number Clinical Trials.gov identifier : NCT00092677 Background —Transapical  transcatheter aortic valve implantation  is generally perceived to be associated with increased morbidity compared with transfemoral transcatheter aortic valve implantation . We aim ed to compare access-related complications and survival using propensity score matching . Methods and Results — Prospect i ve , single-center registry of 1000 consecutive patients undergoing transapical and transfemoral transcatheter aortic valve implantation between May 2008 and April 2012 .  Transapical was performed in 413 patients and transfemoral in 587 patients . Patients with transapical access were less often women and less had pulmonary hypertension . Further they had more peripheral arterial disease , coronary artery disease , carotid stenosis , and recurrent surgery and a higher logistic EuroSCORE I ( 24.3%±16.2 % for transapical versus 22.2%±16.2 % for transfemoral ; P<0.01 ) . After building 2 propensity score – matched groups of 354 patients each with either access route ( total 708 patients ) , baseline characteristics were comparable . In this analysis , there was no significant difference in 30 day mortality ( 5.9 % transapical versus 8.5 % transfemoral ; P=0.19 ) , the rate of myocardial infa rct ion ( 2.5 % transapical versus 2.0 % transfemoral ; P=0.61 ) , stroke ( 2.0 % transapical versus 2.3 % transfemoral ; P=0.79 ) , bleeding complications , pacemaker implantation rates , or moderate aortic insufficiency . Stage 1 renal complications were more common in transapical patients ( odds ratio , 2.81 ; 95 % confidence interval , 1.93–4.09 ) , whereas major vascular complications were less common ( odds ratio , 0.14 ; 95 % confidence interval , 0.06–0.29 ) . Survival probability over the long term was not statistically different ( hazard ratio , 0.89 ; 95 % confidence interval , 0.72–1.10 ; log-rank Test , P=0.27 ) . Conclusions —The data demonstrate that in an experienced multidisciplinary heart team , either access route can be performed with comparable results OBJECTIVES This study sought to evaluate the incidence , predictive factors , and prognostic value of  new-onset atrial fibrillation ( NOAF ) following transcatheter aortic valve implantation ( TAVI ) .  BACKGROUND Very few data exist on the occurrence of NOAF following TAVI . METHODS A total of 138 consecutive patients with no prior history of atrial fibrillation ( AF ) underwent TAVI with a balloon-exp and able valve . Patients were on continuous electrocardiogram monitoring until hospital discharge , and NOAF was defined as any episode of AF lasting > 30 s. All clinical , echocardiographic , procedural , and follow-up data were prospect ively collected . RESULTS NOAF occurred in 44 patients ( 31.9 % ) at a median time of 48 h ( interquartile range : 0 to 72 h ) following TAVI . The predictive factors of NOAF were left atrial ( LA ) size ( odds ratio [ OR ] : 1.21 for each increase in 1 mm/m(2 ) , 95 % confidence interval [ CI ] : 1.09 to 1.34 , p < 0.0001 ) and transapical approach ( OR : 4.08 , 95 % CI : 1.35 to 12.31 , p = 0.019 ) . At 30-day follow-up , NOAF was associated with a higher rate of stroke/systemic embolism ( 13.6 % vs. 3.2 % , p = 0.021 , p = 0.047 after adjustment for baseline differences between groups ) , with no differences in mortality rate between groups ( NOAF : 9.1 % , no-NOAF : 6.4 % , p = 0.57 ) . At a median follow-up of 12 months ( interquartile range : 5 to 20 months ) , a total of 27 patients ( 19.6 % ) had died , with no differences between the NOAF ( 15.9 % ) and no-NOAF ( 21.3 % ) groups , p = 0.58 . The cumulative rate of stroke and stroke/systemic embolism at follow-up were 13.6 % and 15.9 % , respectively , in the NOAF group versus 3.2 % in the no-NOAF group ( p = 0.039 , adjusted p = 0.037 for stroke ; p = 0.020 , adjusted p = 0.023 for stroke/systemic embolism ) . CONCLUSIONS NOAF occurred in about one-third of the patients with no prior history of AF undergoing TAVI and its incidence was increased in patients with larger LA size and those undergoing transapical TAVI . NOAF was associated with a higher rate of stroke/systemic embolism , but not a higher mortality , at 30 days and at 1-year follow-up BACKGROUND Common clinical practice recommends dual antiplatelet therapy ( DAPT ) for  transcatheter aortic valve implantation ( TAVI ) . The aim of the study was to evaluate , in a double blind r and omized study , the safety of TAVI , with adjunctive pharmacotherapy consisting of single antiplatelet therapy . METHODS AND RESULTS From April 2010 to April 2011 , 120 consecutive patients , undergoing TAVI , have been enrolled in 
    Output:
    
Female sex , chronic kidney disease , enrollment date , and new-onset atrial fibrillation were predictors of CVE post-TAVR .
This study provides effect estimates to identify high-risk TAVR patients for early CVE , providing possible guidance for tailored preventive strategies