***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: BACKGROUND Neurological complications after  transcatheter aortic valve replacement ( TAVR )  may be reduced with transcatheter cerebral embolic protection ( TCEP ) . OBJECTIVES This study evaluated the safety and efficacy of TCEP during TAVR . METHODS Nineteen centers r and omized 363 patients undergoing TAVR to a safety arm ( n = 123 ) , device imaging ( n = 121 ) , and control imaging ( n = 119 ) . The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events ( MACCE ) at 30 days , and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days . Patients underwent neurocognitive assessment s , and the debris captured was analyzed . RESULTS The rate of MACCE ( 7.3 % ) was noninferior to the performance goal ( 18.3 % , pnoninferior < 0.001 ) and not statistically different from that of the control group ( 9.9 % ; p = 0.41 ) . New lesion volume was 178.0 mm3 in control subjects and 102.8 mm3 in the device arm ( p = 0.33 ) . A post hoc multivariable analysis identified pre-existing lesion volume and valve type as predictors of new lesion volume . Strokes at 30 days were 9.1 % in control subjects and 5.6 % in patients with devices ( p = 0.25 ) Neurocognitive function was similar in control subjects and patients with devices , but there was a correlation between lesion volume and neurocognitive decline ( p = 0.0022 ) . Debris found within filters in 99 % of patients included thrombus , calcification , valve tissue , artery wall , and foreign material . CONCLUSIONS TCEP was safe , captured embolic debris in 99 % of patients , and did not change neurocognitive function . Reduction in new lesion volume on magnetic resonance scans was not statistically significant . ( Cerebral Protection in Transcatheter Aortic Valve Replacement [ SENTINEL ] ; NCT02214277 ) AIMS Based on r and omized trials using first-generation devices , transcatheter aortic valve replacement ( TAVR ) is well established in the treatment of high-risk ( HR ) patients with severe aortic stenosis ( AS ) . To date , there is a paucity of adjudicated , prospect i ve data evaluating outcomes with newer generation devices and in lower risk patients . We report early outcomes of a large , multicentre registry of inoperable , HR , and intermediate-risk ( IR ) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve ( THV ) .  METHODS AND RESULTS Patients with severe , symptomatic AS ( 583 high surgical risk or inoperable and 1078 IR ) were enrolled in a multicentre , non-r and omized registry at 57 sites in the USA and Canada . All patients received TAVR with the SAPIEN 3 system via transfemoral ( n = 1443 , 86.9 % ) and transapical or transaortic ( n = 218 , 13.1 % ) access routes . The rate of 30-day all-cause mortality was 2.2 % in HR/inoperable patients [ mean Society of Thoracic Surgeons ( STS ) score 8.7 % ] and 1.1 % in IR patients ( mean STS score 5.3 % ) ; cardiovascular mortality was 1.4 and 0.9 % , respectively . In HR/inoperable patients , the 30-day rate of major/disabling stroke was 0.9 % , major bleeding 14.0 % , major vascular complications 5.1 % , and requirement for permanent pacemaker 13.3 % . In IR patients , the 30-day rate of major/disabling stroke was 1.0 % , major bleeding 10.6 % , major vascular complications 6.1 % , and requirement for permanent pacemaker 10.1 % . Mean overall Kansas City Cardiomyopathy Question naire score increased from 47.8 to 67.8 ( HR/inoperable , P < 0.0001 ) and 54.7 to 74.0 ( IR , P < 0.0001 ) . Overall , paravalvular regurgitation at 30 days was none/trace in 55.9 % of patients , mild in 40.7 % , moderate in 3.4 % , and severe in 0.0 % . Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days , while aortic valve area increased from 0.69 to 1.67 cm(2 ) . CONCLUSIONS The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation . TRIAL REGISTRATION Clinical Trials.gov # NCT01314313 BACKGROUND We compared transcatheter aortic-valve replacement ( TAVR ) , using a self-exp and ing transcatheter aortic-valve bioprosthesis , with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery . METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center . Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors . Eligible patients were r and omly assigned in a 1:1 ratio to TAVR with the self-exp and ing transcatheter valve ( TAVR group ) or to surgical aortic-valve replacement ( surgical group ) . The primary end point was the rate of death from any cause at 1 year , evaluated with the use of both noninferiority and superiority testing . RESULTS A total of 795 patients underwent r and omization at 45 centers in the United States . In the as-treated analysis , the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group ( 14.2 % vs. 19.1 % ) , with an absolute reduction in risk of 4.9 percentage points ( upper boundary of the 95 % confidence interval , -0.4 ; P<0.001 for noninferiority ; P = 0.04 for superiority ) . The results were similar in the intention-to-treat analysis . In a hierarchical testing procedure , TAVR was noninferior with respect to echocardiographic indexes of valve stenosis , functional status , and quality of life . Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke . CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk , TAVR with a self-exp and ing transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement . ( Funded by Medtronic ; U.S. CoreValve High Risk Study Clinical Trials.gov number , NCT01240902 . ) Background —New generation transcatheter heart valves ( THV ) may improve clinical outcomes of  transcatheter aortic valve implantation .  Methods and Results —In a nationwide , prospect i ve , multicenter cohort study ( Swiss Transcatheter Aortic Valve Implantation Registry , NCT01368250 ) , outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV ( S3 ) versus the Sapien XT THV ( XT )  were investigated . An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients . Postprocedural mean transprosthetic gradient ( 6.5±3.0 versus 7.8±6.3 mm Hg , P=0.17 ) did not differ between S3 and XT patients , respectively . The rate of more than mild paravalvular regurgitation ( 1.3 % versus 5.3 % , P=0.04 ) and of vascular ( 5.3 % versus 16.9 % , P<0.01 ) complications were significantly lower in S3 patients . A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve ( 17.0 % versus 11.0 % , P=0.01 ) . There were no significant differences for disabling stroke ( S3 1.3 % versus XT 3.1 % , P=0.29 ) and all-cause mortality ( S3 3.3 % versus XT 4.5 % , P=0.27 ) . Conclusions —The use of the new generation S3 balloon-exp and able THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT . Transcatheter aortic valve implantation using the newest generation balloon-exp and able THV is associated with a low risk of stroke and favorable clinical outcomes . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01368250 BACKGROUND Transcatheter aortic-valve implantation ( TAVI ) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses . We report the results of a prospect i ve multicenter study of the French national transcatheter aortic-valve implantation registry , FRANCE 2 . METHODS All TAVIs performed in France , as listed in the FRANCE 2 registry , were prospect ively included in the study . The primary end point was death from any cause . RESULTS A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers . The mean ( ±SD ) age was 82.7±7.2 years ; 49 % of the patients were women . All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement .  Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9 % and 33.1 % of patients , respectively . Approaches were either transarterial ( transfemoral , 74.6 % ; subclavian , 5.8 % ; and other , 1.8 % ) or transapical ( 17.8 % ) . The procedural success rate was 96.9 % . Rates of death at 30 days and 1 year were 9.7 % and 24.0 % , respectively . At 1 year , the incidence of stroke was 4.1 % , and the incidence of periprosthetic aortic regurgitation was 64.5 % . In a multivariate model , a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation ( EuroSCORE ) , New York Heart Association functional class III or IV symptoms , the use of a transapical TAVI approach , and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival . CONCLUSIONS This prospect i ve registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis , in whom TAVI appeared to be a reasonable option . ( Funded by Edwards Lifesciences and Medtronic . ) OBJECTIVES The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation ( TAVI )  , regardless of technology or access route , and to evaluate their clinical outcome over the mid to long term . BACKGROUND Although a substantial body of data exists in relation to early clinical outcomes after TAVI , there are few data on outcomes beyond 1 year in any notable number of patients . METHODS The U.K. TAVI ( United Kingdom Transcatheter Aortic Valve Implantation ) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom . Data were collected prospect ively on 870 patients undergoing 877 TAVI procedures up until December 31 , 2009 . Mortality tracking was achieved in 100 % of patients with mortality status reported as of December 2010 . RESULTS Survival at 30 days was 92.9 % , and it was 78.6 % and 73.7 % at 1 year and 2 years , respectively . There was a marked attrition in survival between 30 days and 1 year . In a univariate model , survival was significantly adversely affected by renal dysfunction , the presence of coronary artery disease , and a nontransfemoral approach ; whereas left ventricular function ( ejection fraction < 30 % ) , the presence of moderate/severe aortic regurgitation , and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model . CONCLUSIONS Midterm to long-term survival after TAVI was encouraging in this high-risk patient population , although a substantial proportion of patients died within the first year BACKGROUND Many patients with severe aortic stenosis and coexisting conditions are not c and i date s for surgical replacement of the aortic valve . Recently , transcatheter aortic-valve implantation ( TAVI ) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis . METHODS We r and omly assigned patients with severe aortic 
    Output:
    
Patients receiving the S3V  had lower risk of PVL , MVC , bleeding , mortality , and stroke .
PPI was somewhat higher in the S3V group .
S3V implantation was faster and used less contrast