human
***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 After the approval of transcatheter aortic valve replacement ( TAVR ) for high-risk or inoperable patients with severe aortic stenosis ( AS ) , many low- and moderate-volume TAVR programs were initiated . Contemporary outcomes from these newly initiated centres remain unknown . METHODS In March 2013 , our institution was authorized by the Québec Ministry of Health to perform 30 TAVR procedures .  After thorough clinical screening and imaging evaluation , suitable patients underwent transfemoral TAVR with the balloon-exp and able SAPIEN XT ( Edwards Lifesciences , Irvine , CA ) transcatheter heart valve ( THV ) . In-hospital and 30-day outcomes were prospect ively collected and reported according to Valve Academic Research Consortium 2 guidelines . RESULTS From April 2013 to January 2014 , 30 consecutive high-risk ( n = 16 [ 53.3 % ] ) or inoperable ( n = 14 [ 46.7 % ] ) patients ( mean age , 84.6 years ; mean Society of Thoracic Surgery score , 7 ) with symptomatic severe AS underwent transfemoral TAVR . No catastrophic intraprocedural complications such as annulus rupture , valve embolization , aortic dissection , or coronary occlusion occurred , and there were no deaths at 30 days . Disabling stroke occurred in 1 ( 3.3 % ) patient 48 hours after THV implantation . Major vascular complications and major bleeding occurred in 1 ( 3.3 % ) patient . No moderate or severe paravalvular leak was observed . The median length of stay was 2 ( 1 - 3 ) days , with 8 ( 26.7 % ) patients discharged within 24 hours after the procedure . CONCLUSIONS Excellent outcomes can be achieved in newly initiated relatively low-volume centres , which compares favorably to previously published large series . Important considerations include appropriate team training , rigorous patient screening , use of multimodality imaging techniques , a heart team approach , constant integration of lessons learned from larger published experiences , and maintaining a recommended minimum volume of 25 cases per year INTRODUCTION Little is known about the early and late performance of the 31 mm CoreValve Revalving System ( CRS , Medtronic Inc. , Galway , Irel and ) . Our aim was to compare acute and long-term results of the 31 mm CRS with other valve sizes . METHODS Consecutive patients undergoing transcatheter aortic valve implantation ( TAVI ) with CRS in nine Italian centers were prospect ively included and dichotomized according to prosthesis size in two different groups , as follows : 31 mm and other valve sizes ( i.e. , 23 , 26 , and 29 mm combined ) . End points were defined according to Valve Academic Research Consortium definitions . Propensity score matching was performed . RESULTS In total , 2069 patients ( n=169 [ 8 % ] in the 31 mm group and n=1900 [ 92 % ] in the other valve sizes group ) were included . After propensity matching , the implantation of the 31 mm valve was associated with lower rates of procedural- ( 91.3 % vs. 98.1 % , p=0.030 ) and device-success ( 88.5 % vs. 97.1 % , p=0.016 ) , longer procedural time ( 120 [ 80 - 180 ] min . vs. 90 [ 60 - 120 ] min . , p<0.001 ) , and higher rates of implantation of a second valve ( 10.6 % vs. 2.9 % , respectively , p=0.027 ) . The rates of permanent pacemaker implantation in the 31 mm group were higher but not statistically different from other valve sizes ( 41.7 % vs. 30.9 % , respectively , p=0.149 ) . Significant improvement , without between-group differences , was observed in NYHA functional class . Cardiovascular death was lower in the 31 mm valve group through 2-years ( 3.8 % vs. 13.5 % , respectively , p=0.014 ) . CONCLUSIONS The acute performance of the 31 mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes 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 INTRODUCTION Transcatheter aortic valve implantation ( TAVI ) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis . Given the unique characteristics of Asian population s , questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed . We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions . METHODS This prospect i ve study recruited 59 patients from a major academic medical centre in Singapore . The main outcomes were two-year survival rates , peri-procedural complications , symptom improvement , valvular function and assessment of learning curve . RESULTS Mean age was 76.8 years ( 61.0 % male ) , mean body surface area 1.6 m2 and mean logistic EuroSCORE 18.7 % . Survival was 93.2 % , 86.0 % and 79.1 % at 30 days , one year and two years , respectively . At 30 days post TAVI , the rate of stroke was 1.7 % , life-threatening bleeding 5.1 % , acute kidney injury 25.0 % , major vascular complication 5.1 % , and new permanent pacemaker implantation 6.8 % . 29.3 % of TAVI patients were rehospitalised ( 47.1 % cardiovascular-related ) within one year . These composite outcomes were measured : device success ( 93.2 % ) ; early safety ( 79.7 % ) ; clinical efficacy ( 66.1 % ) ; and time-related valve safety ( 84.7 % ) . Univariate analysis found these predictors of two-year all-cause mortality : logistic EuroSCORE ( hazard ratio [ HR ] 1.07 ; p < 0.001 ) ; baseline estimated glomerular filtration rate ( HR 0.97 ; p = 0.048 ) ; and acute kidney injury ( HR 5.33 ; p = 0.022 ) . Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality ( HR 14.64 ; p = 0.008 ) . CONCLUSION Despite the unique clinical differences in Asian population s , this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI BACKGROUND Recent miniaturization of an insertable cardiac monitor ( ICM ) may make it possible to move device insertion from a hospital to office setting . However , the safety of this strategy is unknown . OBJECTIVES The primary objective was to compare the safety of inserting the Reveal LINQ ICM in an office vs a hospital environment . Ancillary objectives included summarizing device- and procedure-related adverse events and responses to a physician question naire . METHODS Five hundred twenty-one patients indicated for an ICM were r and omized ( 1:1 ratio ) to undergo ICM insertion in a hospital or office environment at 26 centers in the United States in the Reveal LINQ In-Office 2 study ( Clinical Trials.gov identifier NCT02395536 ) . Patients were followed for 90 days . RESULTS ICM insertion was successful in all 482 attempted patients ( office : 251 ; hospital : 231 ) . The untoward event rate ( composite of unsuccessful insertion and ICM- or insertion-related complications ) was 0.8 % ( 2 of 244 ) in the office and 0.9 % ( 2 of 227 ) in the hospital ( 95 % confidence interval , -3.0 % to 2.9 % ; 5 % noninferiority : P < .001 ) . In addition , adverse events occurred during 2.5 % ( 6 of 244 ) of office and 4.4 % ( 10 of 227 ) of hospital insertions ( 95 % confidence interval [ office minus inhospital rates ] , -5.8 % to 1.9 % ; 5 % noninferiority : P < .001 ) . Physicians indicated that for procedures performed in an office vs a hospital , there were fewer delays > 15 minutes ( 16 % vs 35 % ; P < .001 ) and patient response was more often " very positive . " Physicians considered the office location " very convenient " more frequently than the hospital location ( 85 % vs 27 % ; P < .001 ) . CONCLUSION The safety profile for the insertion of the Reveal LINQ ICM is excellent irrespective of insertion environment . These results may exp and site of service options for LINQ insertion OBJECTIVES The study sought to examine the safety and performance of transcatheter aortic valve replacement ( TAVR ) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR . BACKGROUND Although women comprise 50 % of patients with symptomatic severe aortic stenosis undergoing TAVR  , the optimal treatment strategy remains undetermined . METHODS The WIN-TAVI ( Women 's INternational Transcatheter Aortic Valve Implantation ) registry is a multinational , prospect i ve , observational registry of women undergoing TAVR for aortic stenosis , conducted without any external funding . The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days ( composite of mortality , stroke , major vascular complication , life-threatening bleeding , stage 2 or 3 acute kidney injury , coronary artery obstruction , or repeat procedure for valve-related dysfunction ) . RESULTS Between January 2013 and December 2015 , 1,019 women were enrolled across 19 European and North American centers . The mean patient age was 82.5 ± 6.3 years , mean EuroSCORE I was 17.8 ± 11.7 % and mean Society of Thoracic Surgeons score was 8.3 ± 7.4 % .  TAVR was performed via transfemoral access in 90.6 % and new-generation devices were used in 42.1 % . In more than two-thirds of cases , an Edwards SAPIEN 23 mm ( Edwards Lifesciences , Irvine , California ) or Medtronic CoreValve ≤26 mm ( Medtronic Inc. , Minneapolis , Minnesota ) device was implanted . The 30-day VARC-2 composite endpoint occurred in 14.0 % with 3.4 % all-cause mort 
    Output:
    
agent
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
***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 After the approval of transcatheter aortic valve replacement ( TAVR ) for high-risk or inoperable patients with severe aortic stenosis ( AS ) , many low- and moderate-volume TAVR programs were initiated . Contemporary outcomes from these newly initiated centres remain unknown . METHODS In March 2013 , our institution was authorized by the Québec Ministry of Health to perform 30 TAVR procedures .  After thorough clinical screening and imaging evaluation , suitable patients underwent transfemoral TAVR with the balloon-exp and able SAPIEN XT ( Edwards Lifesciences , Irvine , CA ) transcatheter heart valve ( THV ) . In-hospital and 30-day outcomes were prospect ively collected and reported according to Valve Academic Research Consortium 2 guidelines . RESULTS From April 2013 to January 2014 , 30 consecutive high-risk ( n = 16 [ 53.3 % ] ) or inoperable ( n = 14 [ 46.7 % ] ) patients ( mean age , 84.6 years ; mean Society of Thoracic Surgery score , 7 ) with symptomatic severe AS underwent transfemoral TAVR . No catastrophic intraprocedural complications such as annulus rupture , valve embolization , aortic dissection , or coronary occlusion occurred , and there were no deaths at 30 days . Disabling stroke occurred in 1 ( 3.3 % ) patient 48 hours after THV implantation . Major vascular complications and major bleeding occurred in 1 ( 3.3 % ) patient . No moderate or severe paravalvular leak was observed . The median length of stay was 2 ( 1 - 3 ) days , with 8 ( 26.7 % ) patients discharged within 24 hours after the procedure . CONCLUSIONS Excellent outcomes can be achieved in newly initiated relatively low-volume centres , which compares favorably to previously published large series . Important considerations include appropriate team training , rigorous patient screening , use of multimodality imaging techniques , a heart team approach , constant integration of lessons learned from larger published experiences , and maintaining a recommended minimum volume of 25 cases per year INTRODUCTION Little is known about the early and late performance of the 31 mm CoreValve Revalving System ( CRS , Medtronic Inc. , Galway , Irel and ) . Our aim was to compare acute and long-term results of the 31 mm CRS with other valve sizes . METHODS Consecutive patients undergoing transcatheter aortic valve implantation ( TAVI ) with CRS in nine Italian centers were prospect ively included and dichotomized according to prosthesis size in two different groups , as follows : 31 mm and other valve sizes ( i.e. , 23 , 26 , and 29 mm combined ) . End points were defined according to Valve Academic Research Consortium definitions . Propensity score matching was performed . RESULTS In total , 2069 patients ( n=169 [ 8 % ] in the 31 mm group and n=1900 [ 92 % ] in the other valve sizes group ) were included . After propensity matching , the implantation of the 31 mm valve was associated with lower rates of procedural- ( 91.3 % vs. 98.1 % , p=0.030 ) and device-success ( 88.5 % vs. 97.1 % , p=0.016 ) , longer procedural time ( 120 [ 80 - 180 ] min . vs. 90 [ 60 - 120 ] min . , p<0.001 ) , and higher rates of implantation of a second valve ( 10.6 % vs. 2.9 % , respectively , p=0.027 ) . The rates of permanent pacemaker implantation in the 31 mm group were higher but not statistically different from other valve sizes ( 41.7 % vs. 30.9 % , respectively , p=0.149 ) . Significant improvement , without between-group differences , was observed in NYHA functional class . Cardiovascular death was lower in the 31 mm valve group through 2-years ( 3.8 % vs. 13.5 % , respectively , p=0.014 ) . CONCLUSIONS The acute performance of the 31 mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes 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 INTRODUCTION Transcatheter aortic valve implantation ( TAVI ) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis . Given the unique characteristics of Asian population s , questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed . We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions . METHODS This prospect i ve study recruited 59 patients from a major academic medical centre in Singapore . The main outcomes were two-year survival rates , peri-procedural complications , symptom improvement , valvular function and assessment of learning curve . RESULTS Mean age was 76.8 years ( 61.0 % male ) , mean body surface area 1.6 m2 and mean logistic EuroSCORE 18.7 % . Survival was 93.2 % , 86.0 % and 79.1 % at 30 days , one year and two years , respectively . At 30 days post TAVI , the rate of stroke was 1.7 % , life-threatening bleeding 5.1 % , acute kidney injury 25.0 % , major vascular complication 5.1 % , and new permanent pacemaker implantation 6.8 % . 29.3 % of TAVI patients were rehospitalised ( 47.1 % cardiovascular-related ) within one year . These composite outcomes were measured : device success ( 93.2 % ) ; early safety ( 79.7 % ) ; clinical efficacy ( 66.1 % ) ; and time-related valve safety ( 84.7 % ) . Univariate analysis found these predictors of two-year all-cause mortality : logistic EuroSCORE ( hazard ratio [ HR ] 1.07 ; p < 0.001 ) ; baseline estimated glomerular filtration rate ( HR 0.97 ; p = 0.048 ) ; and acute kidney injury ( HR 5.33 ; p = 0.022 ) . Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality ( HR 14.64 ; p = 0.008 ) . CONCLUSION Despite the unique clinical differences in Asian population s , this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI BACKGROUND Recent miniaturization of an insertable cardiac monitor ( ICM ) may make it possible to move device insertion from a hospital to office setting . However , the safety of this strategy is unknown . OBJECTIVES The primary objective was to compare the safety of inserting the Reveal LINQ ICM in an office vs a hospital environment . Ancillary objectives included summarizing device- and procedure-related adverse events and responses to a physician question naire . METHODS Five hundred twenty-one patients indicated for an ICM were r and omized ( 1:1 ratio ) to undergo ICM insertion in a hospital or office environment at 26 centers in the United States in the Reveal LINQ In-Office 2 study ( Clinical Trials.gov identifier NCT02395536 ) . Patients were followed for 90 days . RESULTS ICM insertion was successful in all 482 attempted patients ( office : 251 ; hospital : 231 ) . The untoward event rate ( composite of unsuccessful insertion and ICM- or insertion-related complications ) was 0.8 % ( 2 of 244 ) in the office and 0.9 % ( 2 of 227 ) in the hospital ( 95 % confidence interval , -3.0 % to 2.9 % ; 5 % noninferiority : P < .001 ) . In addition , adverse events occurred during 2.5 % ( 6 of 244 ) of office and 4.4 % ( 10 of 227 ) of hospital insertions ( 95 % confidence interval [ office minus inhospital rates ] , -5.8 % to 1.9 % ; 5 % noninferiority : P < .001 ) . Physicians indicated that for procedures performed in an office vs a hospital , there were fewer delays > 15 minutes ( 16 % vs 35 % ; P < .001 ) and patient response was more often " very positive . " Physicians considered the office location " very convenient " more frequently than the hospital location ( 85 % vs 27 % ; P < .001 ) . CONCLUSION The safety profile for the insertion of the Reveal LINQ ICM is excellent irrespective of insertion environment . These results may exp and site of service options for LINQ insertion OBJECTIVES The study sought to examine the safety and performance of transcatheter aortic valve replacement ( TAVR ) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR . BACKGROUND Although women comprise 50 % of patients with symptomatic severe aortic stenosis undergoing TAVR  , the optimal treatment strategy remains undetermined . METHODS The WIN-TAVI ( Women 's INternational Transcatheter Aortic Valve Implantation ) registry is a multinational , prospect i ve , observational registry of women undergoing TAVR for aortic stenosis , conducted without any external funding . The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days ( composite of mortality , stroke , major vascular complication , life-threatening bleeding , stage 2 or 3 acute kidney injury , coronary artery obstruction , or repeat procedure for valve-related dysfunction ) . RESULTS Between January 2013 and December 2015 , 1,019 women were enrolled across 19 European and North American centers . The mean patient age was 82.5 ± 6.3 years , mean EuroSCORE I was 17.8 ± 11.7 % and mean Society of Thoracic Surgeons score was 8.3 ± 7.4 % .  TAVR was performed via transfemoral access in 90.6 % and new-generation devices were used in 42.1 % . In more than two-thirds of cases , an Edwards SAPIEN 23 mm ( Edwards Lifesciences , Irvine , California ) or Medtronic CoreValve ≤26 mm ( Medtronic Inc. , Minneapolis , Minnesota ) device was implanted . The 30-day VARC-2 composite endpoint occurred in 14.0 % with 3.4 % all-cause mort 
    Output:
    