***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: OBJECTIVE To evaluate cost-effectiveness of transfemoral TAVR vs surgical replacement ( SAVR ) and its determinants in patients with severe symptomatic aortic stenosis and comparable risk . METHODS Patients were prospect ively recruited in 6 Spanish hospitals and followed up over one year . We estimated adjusted incremental cost-effectiveness ratio ( ICER ) ( Euros per quality -adjusted life-year [ QALY ] gained ) using a net-benefit approach and assessed the determinants of incremental net-benefit of TAVR vs SAVR . RESULTS We analyzed data on 207 patients : 58 , 87 and 62 in the Edwards SAPIEN ( ES ) TAVR , Medtronic-CoreValve ( MC ) TAVR and SAVR groups respectively .  Average cost per patient of ES-TAVR was € 8800 higher than SAVR and the gain in QALY was 0.036 . The ICER was € 148,525/QALY . The cost of MC-TAVR was € 9729 higher than SAVR and the QALY difference was -0.011 ( dominated ) . Results substantially changed in the following conditions : 1 ) in patients with high preoperative serum creatinine the ICERs were € 18,302/QALY and € 179,618/QALY for ES and MC-TAVR respectively ; 2 ) a 30 % reduction in the cost of TAVR devices decreased the ICER for ES-TAVR to € 32,955/QALY ; and 3 ) imputing hospitalization costs from other European countries leads to TAVR being dominant . CONCLUSIONS In countries with relatively low health care costs TAVR is not likely to be cost-effective compared to SAVR in patients with intermediate risk for surgery , mainly because of the high cost of the valve compared to the cost of hospitalization . TAVR could be cost-effective in specific subgroups and in countries with higher hospitalization costs Background — Improving functional status and quality of life are important goals of treatment for patients with severe aortic stenosis . The Kansas City Cardiomyopathy Question naire ( KCCQ ) is a heart failure health status measure and has been used in studies of patients with aortic stenosis . However , its psychometric properties have not yet been evaluated in these patients . Methods and Results — We analyzed data from 955 patients , enrolled in the PARTNER trial of transcatheter aortic valve replacement , to evaluate the reliability , responsiveness , validity , and prognostic importance of the KCCQ in patients with severe aortic stenosis . The KCCQ was administered at baseline and at 1 , 6 , and 12 months after r and omization to medical therapy , transcatheter aortic valve replacement , or surgical valve replacement . Among clinical ly stable patients , there were only small changes in the  KCCQ domain scores over time ( mean differences 0.1–4.2 points ) , and the intraclass correlation coefficients showed good agreement between paired assessment s ( 0.65–0.76 ) . However , the domain scores of patients who underwent transcatheter aortic valve replacement showed large changes after treatment ( mean differences 13–30 points ) . Construct validity was demonstrated by comparing each domain against a relevant reference measure ( Spearman correlations 0.46–0.69 ) . Finally , among 157 patients r and omized to medical management , lower  KCCQ overall summary scores at baseline were strongly associated with an increased risk of mortality during the following 12 months . Conclusions — The KCCQ is a highly reliable , responsive , and valid measure of symptoms , functional status , and quality of life in patients with severe , symptomatic aortic stenosis 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 OBJECTIVES This study sought to compare health status and quality -of-life outcomes for patients with severe aortic stenosis ( AS ) and high surgical risk treated with either transcatheter aortic valve replacement ( TAVR ) or surgical aortic valve replacement ( AVR ) .  BACKGROUND For high-risk patients with severe AS , TAVR has been shown to result in similar 12-month survival but differing adverse events compared with AVR . METHODS We evaluated the health status of 628 patients with severe , symptomatic AS at high risk of surgical complications who were r and omized to either TAVR or AVR in the PARTNER Trial .  Health status was assessed at baseline and 1 , 6 , and 12 months using the Kansas City Cardiomyopathy Question naire , the Short Form-12 , and the EuroQol-5D . RESULTS The primary outcome , the Kansas City Cardiomyopathy Question naire summary score , improved more rapidly with TAVR , but was similar for the 2 groups at 6 and 12 months . However , there was a significant interaction between the benefit of TAVR and access site ( transapical vs. transfemoral ) . Patients eligible for transfemoral TAVR demonstrated significant health status benefits with TAVR versus AVR at 1 month ( difference , 9.9 points ; 95 % confidence interval : 4.9 to 14.9 ; p < 0.001 ) , whereas patients treated via the TA approach demonstrated no benefits with TAVR compared with AVR at any time point . Results for Kansas City Cardiomyopathy Question naire subscales and generic measures demonstrated similar patterns . CONCLUSIONS In high-risk patients with severe AS , health status improved substantially between baseline and 1 year after either TAVR or AVR . TAVR via the transfemoral , but not the transapical route , was associated with a short-term advantage compared with surgery . ( Placement of AoRTic TraNscathetER Valve [ PARTNER ] trial ; NCT00530894 ) BACKGROUND The Placement of Aortic Transcatheter Valves 2A ( PARTNER-2A ) r and omized trial compared outcomes of transfemoral transcatheter and surgical aortic valve replacement ( SAVR ) in intermediate-risk patients with severe aortic stenosis . The purpose of the present study was to perform an in-depth analysis of outcomes after SAVR in the PARTNER-2A trial . METHODS From January 2012 to January 2014 , 937 patients underwent SAVR at 57 centers . Mean age was 82 ± 6.7 years and 55 % were men . Less-invasive operations were performed in 140 patients ( 15 % ) and concomitant procedures in 198 patients ( 21 % ) . Major outcomes and echocardiograms were adjudicated by an independent events committee . Follow-up was 94 % complete to 2 years . RESULTS Operative mortality was 4.1 % ( n = 38 , Society of Thoracic Surgeons predicted risk of mortality : 5.2 % ± 2.3 % ) , observed to expected ratio ( O/E ) was 0.8 , and in-hospital stroke was 5.4 % ( n = 51 ) , twice expected . Aortic clamp and bypass times were 75 ± 30 minutes and 104 ± 46 minutes , respectively . Patients having severe prosthesis-patient mismatch ( n = 260 , 33 % ) had similar survival to patients without ( p > 0.9 ) , as did patients undergoing less-invasive SAVR ( p = 0.3 ) . Risk factors for death included cachexia ( p = 0.004 ) , tricuspid regurgitation ( p = 0.01 ) , coronary artery disease ( p = 0.02 ) , preoperative atrial fibrillation ( p = 0.001 ) , higher white blood cell count ( p < 0.0001 ) , and lower hemoglobin ( p = 0.0002 ) . CONCLUSIONS In this adjudicated prospect i ve study , SAVR in intermediate-risk patients had excellent results at 2 years . However , there were more in-hospital strokes than expected , most likely attributable to m and atory neurologic assessment after the procedure . No pronounced structural valve deterioration was found during 2-year follow-up . Continued long-term surveillance remains important Objective Transcatheter aortic valve implantation ( TAVI ) is generally more expensive than surgical aortic valve replacement ( SAVR ) due to the high cost of the device . Our objective was to underst and the patient and procedural drivers of cumulative healthcare costs during the index hospitalisation for these procedures . Design All patients undergoing TAVI , isolated SAVR or combined SAVR+coronary artery bypass grafting ( CABG ) at 7 hospitals in Ontario , Canada were identified during the fiscal year 2012–2013 . Data were obtained from a prospect i ve registry . Cumulative healthcare costs during the episode of care were determined using microcosting . To identify drivers of healthcare costs , multivariable hierarchical generalised linear models with a logarithmic link and γ distribution were developed for TAVI , SAVR and SAVR+CABG separately . Results Our cohort consisted of 1310 patients with aortic stenosis , of whom 585 underwent isolated SAVR , 518 had SAVR+CABG and 207 underwent TAVI .  The median costs for the index hospitalisation for isolated SAVR were $ 21 811 ( IQR $ 18 148–$30 498 ) , while those for SAVR+CABG were $ 27 256 ( IQR $ 21 741–$39 000 ) , compared with $ 42 742 ( IQR $ 37 295–$56 196 ) for TAVI . For SAVR , the major patient-level drivers of costs were age > 75 years , renal dysfunction and active endocarditis . For TAVI , chronic lung disease was a major patient-level driver . Procedural drivers of cost  for TAVI included a non-transfemoral approach . A prolonged intensive care unit stay was associated with increased costs for all procedures . Conclusions We found wide variation in healthcare costs  for SAVR compared with TAVI , with different patient-level drivers as well as potentially modifiable procedural factors . These highlight areas of further study to optimise healthcare delivery OBJECTIVES This study sought to compare the health status outcomes for patients treated with either self-exp and ing transcatheter aortic valve replacement ( TAVR ) or surgical aortic valve replacement ( AVR ) .  BACKGROUND In patients at increased surgical risk , TAVR with a self-exp and ing bioprosthesis is associated with improved 1-year survival compared with AVR . However , elderly patients may be just as concerned with quality -of-life improvement as with prolonged survival as a goal of treatment . METHO 
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However , compared with SAVR , TAVI had a higher risk of some complications and a lower risk of others .
People who had undergone TAVI reported reduced physical and psychological effects and a shorter recovery time .
People said that TAVI increased their quality of life in the short-term immediately after the procedure .
Conclusions In people with severe , symptomatic aortic valve stenosis at intermediate surgical risk , TAVI was similar to SAVR with respect to the composite endpoint of all-cause mortality or disabling stroke .
However , the two treatments had different patterns of complications .
The study authors also noted that longer follow-up is needed to assess the durability of the TAVI valve .
Compared with SAVR , TAVI may provide good value for money , but publicly funding TAVI in Ontario would result in additional costs over the next 5 years .
People with aortic valve stenosis who had undergone TAVI appreciated its less invasive nature and reported a substantial reduction in physical and psychological effects after the procedure , improving their quality of life