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: 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 OBJECTIVES The aim of the CoreValve prospect i ve , international , post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation ( PPI )  after transcatheter aortic valve replacement with the Medtronic CoreValve System ( Minneapolis , Minnesota ) using optimized implantation techniques and application of international guidelines on cardiac pacing . BACKGROUND Conduction disturbances are a frequent complication of transcatheter aortic valve replacement . The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI . METHODS The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth ( ≤6 mm below the aortic annulus ) . The timing and resolution of all new-onset conduction disturbances were analyzed . RESULTS A total of 194 patients were treated . The overall rate of PPI for Class I/II indications was 18.2 % . An optimal depth was reached in 43.2 % of patients , with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm , compared with those with deeper implants ( 13.3 % vs. 21.1 % ; p = 0.14 ) . In a paired analysis , new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4 % and 39.0 % of patients , respectively , and resolved spontaneously within 30 days in 43.2 % and 73.9 % , respectively . In patients with new PPI , the rate of intrinsic sinus rhythm increased from 25.9 % at 7 days to 59.3 % at 30 days ( p = 0.004 ) . CONCLUSIONS Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement , compared with results reported in previous studies . ( CoreValve Advance-II Study : Prospect i ve International Post-Market Study [ ADVANCE II ] ; NCT01624870 ) OBJECTIVES This study sought to evaluate this transcatheter aortic valve ( TAV ) bioprosthesis in patients who are poorly suitable for surgical aortic valve ( AV ) replacement . BACKGROUND A novel self-exp and able TAV bioprosthesis was design ed to provide a low-profile delivery system , conformable annular sealing , and the ability to resheath and reposition during deployment . METHODS The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States . Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria . An independent echocardiography laboratory was used to evaluate hemodynamic outcomes . RESULTS Patients were elderly ( 83.3 ± 7.2 years of age ) and had high surgical risk ( Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4 % ) . The majority of patients ( 89.5 % ) were treated by iliofemoral access . Resheathing or recapturing was performed in 22.6 % of patients ; more than 1 valve was required in 3 patients ( 1.3 % ) . The 30-day outcomes included all-cause mortality ( 2.5 % ) , disabling stroke ( 3.3 % ) , major vascular complications ( 7.5 % ) , life-threatening or disabling bleeding ( 7.1 % ) , and new permanent pacemaker ( 16.4 % ) . AV hemodynamics were markedly improved at 30 days : the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg ( p < 0.001 ) and AV area increased from 0.6 ± 0.2 cm2 to 1.9 ± 0.5 cm2 ( p < 0.001 ) . Moderate residual paravalvular leak was identified in 5.3 % of patients . CONCLUSIONS We conclude that this novel self-exp and ing TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery . ( Medtronic CoreValve Evolut R U.S. Clinical Study ; NCT02207569 ) Aims RESPOND is a prospect i ve , open-label , single-arm study evaluating the outcomes following transcatheter aortic valve implantation ( TAVI ) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis . Methods and results RESPOND enrolled 1014 patients at sites across Europe , New Zeal and , and Latin America ; 996 patients received a Lotus Valve ( mean age : 80.8 years ; 50.8 % female ; Society of Thoracic Surgeons score : 6.0 ± 6.9 ) . Repositioning was attempted in 29.2 % of patients , with 99 % success . The rate of all-cause mortality in the intent-to-treat population at 30 days ( primary endpoint ) was 2.6 % ( P < 0.001 vs. pre-specified performance goal ) . Thirty-day clinical follow-up was completed for 97.3 % of patients . Among patients who received a Lotus Valve , the 30-day overall and disabling stroke rates were 3.0 % and 2.2 % , respectively . The 30-day permanent pacemaker implantation rate was 30.0 % in all patients , and 34.6 % in pacemaker-naïve patients . Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory . Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge ( P < 0.001 ) . Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge ( P < 0.001 ) . At hospital discharge , paravalvular leak ( PVL ) was absent or trace in 92 % of patients ; no patients had severe PVL , 0.3 % of patients exhibited moderate PVL , and 7.7 % of patients had mild PVL . Clinical follow-up in RESPOND will extend to 5 years . Conclusion The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice . Trial registration Clinical Trials.gov # NCT 02031302 AIMS Long-term outcomes are available for first-generation transcatheter heart valves but data on second-generation devices are scarce . We aim ed to provide an oversight of all patients implanted with a second-generation valve in our centre . METHODS AND RESULTS From April 2012 to July 2016 , 219 patients were enrolled in this prospect i ve single-centre experience ; they received either the transapical ACURATE TA ( n=99 ) or the transfemoral ACURATE neo ( n=120 ) prosthesis . Data were collected during the hospital stay and telephone follow-ups were conducted at 30 days post procedure and annually thereafter . Patients were 80.9±4.4 years old with a mean logistic EuroSCORE I of 19.3±13.9 % . Transapical patients had significantly more comorbidities at baseline . Post intervention , mean gradient was reduced to 10.6±9.2 mmHg , and 1.9 % had moderate paravalvular regurgitation . Mean follow-up time , based on the last patient contact , was 217±188 days for the transfemoral and 525±413 days for the transapical group . Thirty-day mortality was 2.5 % and 4.0 % , and one-year Kaplan-Meier survival was 94.8 % ( 95 % CI : 87.5 - 97.9 ) and 81.9 % ( 95 % CI : 72.0 - 88.5 ) , respectively . At two years , survival was 64.9 % ( 95 % CI : 52.6 - 74.7 ) for transapical patients . CONCLUSIONS This early single-centre experience showed very good safety and performance outcomes in patients treated with the ACURATE prostheses Abstract OBJECTIVES : The ACURATE TATM system is a self-exp and ing transcatheter heart valve system design ed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials . The SAVI-1 and SAVI-2 registries aim ed to assess whether these promising outcomes can be translated into all-comers clinical routine . METHODS : From November 2011 to 2012 ( SAVI-1 ) , and November 2013 to 2014 ( SAVI-2 ) , a total of 500 patients were enrolled in the prospect i ve , all-comers , multicentre , multinational SAVI registries . Patients were treated according to the st and ard of care at their respective hospitals . We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2 . RESULTS : Patients were 80.8 ± 6.1 years old , the mean logistic EuroSCORE-I was 23.4 ± 14.3 % . Valves were deployed under rapid pacing in 71.3 % of the procedures in SAVI-1 , and in 3.6 % in SAVI- 
    Output:
    
agent
Specific recommendations for implantation of each prosthesis , taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors , may be needed to reduce the risk of PPI
***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 OBJECTIVES The aim of the CoreValve prospect i ve , international , post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation ( PPI )  after transcatheter aortic valve replacement with the Medtronic CoreValve System ( Minneapolis , Minnesota ) using optimized implantation techniques and application of international guidelines on cardiac pacing . BACKGROUND Conduction disturbances are a frequent complication of transcatheter aortic valve replacement . The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI . METHODS The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth ( ≤6 mm below the aortic annulus ) . The timing and resolution of all new-onset conduction disturbances were analyzed . RESULTS A total of 194 patients were treated . The overall rate of PPI for Class I/II indications was 18.2 % . An optimal depth was reached in 43.2 % of patients , with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm , compared with those with deeper implants ( 13.3 % vs. 21.1 % ; p = 0.14 ) . In a paired analysis , new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4 % and 39.0 % of patients , respectively , and resolved spontaneously within 30 days in 43.2 % and 73.9 % , respectively . In patients with new PPI , the rate of intrinsic sinus rhythm increased from 25.9 % at 7 days to 59.3 % at 30 days ( p = 0.004 ) . CONCLUSIONS Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement , compared with results reported in previous studies . ( CoreValve Advance-II Study : Prospect i ve International Post-Market Study [ ADVANCE II ] ; NCT01624870 ) OBJECTIVES This study sought to evaluate this transcatheter aortic valve ( TAV ) bioprosthesis in patients who are poorly suitable for surgical aortic valve ( AV ) replacement . BACKGROUND A novel self-exp and able TAV bioprosthesis was design ed to provide a low-profile delivery system , conformable annular sealing , and the ability to resheath and reposition during deployment . METHODS The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States . Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria . An independent echocardiography laboratory was used to evaluate hemodynamic outcomes . RESULTS Patients were elderly ( 83.3 ± 7.2 years of age ) and had high surgical risk ( Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4 % ) . The majority of patients ( 89.5 % ) were treated by iliofemoral access . Resheathing or recapturing was performed in 22.6 % of patients ; more than 1 valve was required in 3 patients ( 1.3 % ) . The 30-day outcomes included all-cause mortality ( 2.5 % ) , disabling stroke ( 3.3 % ) , major vascular complications ( 7.5 % ) , life-threatening or disabling bleeding ( 7.1 % ) , and new permanent pacemaker ( 16.4 % ) . AV hemodynamics were markedly improved at 30 days : the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg ( p < 0.001 ) and AV area increased from 0.6 ± 0.2 cm2 to 1.9 ± 0.5 cm2 ( p < 0.001 ) . Moderate residual paravalvular leak was identified in 5.3 % of patients . CONCLUSIONS We conclude that this novel self-exp and ing TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery . ( Medtronic CoreValve Evolut R U.S. Clinical Study ; NCT02207569 ) Aims RESPOND is a prospect i ve , open-label , single-arm study evaluating the outcomes following transcatheter aortic valve implantation ( TAVI ) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis . Methods and results RESPOND enrolled 1014 patients at sites across Europe , New Zeal and , and Latin America ; 996 patients received a Lotus Valve ( mean age : 80.8 years ; 50.8 % female ; Society of Thoracic Surgeons score : 6.0 ± 6.9 ) . Repositioning was attempted in 29.2 % of patients , with 99 % success . The rate of all-cause mortality in the intent-to-treat population at 30 days ( primary endpoint ) was 2.6 % ( P < 0.001 vs. pre-specified performance goal ) . Thirty-day clinical follow-up was completed for 97.3 % of patients . Among patients who received a Lotus Valve , the 30-day overall and disabling stroke rates were 3.0 % and 2.2 % , respectively . The 30-day permanent pacemaker implantation rate was 30.0 % in all patients , and 34.6 % in pacemaker-naïve patients . Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory . Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge ( P < 0.001 ) . Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge ( P < 0.001 ) . At hospital discharge , paravalvular leak ( PVL ) was absent or trace in 92 % of patients ; no patients had severe PVL , 0.3 % of patients exhibited moderate PVL , and 7.7 % of patients had mild PVL . Clinical follow-up in RESPOND will extend to 5 years . Conclusion The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice . Trial registration Clinical Trials.gov # NCT 02031302 AIMS Long-term outcomes are available for first-generation transcatheter heart valves but data on second-generation devices are scarce . We aim ed to provide an oversight of all patients implanted with a second-generation valve in our centre . METHODS AND RESULTS From April 2012 to July 2016 , 219 patients were enrolled in this prospect i ve single-centre experience ; they received either the transapical ACURATE TA ( n=99 ) or the transfemoral ACURATE neo ( n=120 ) prosthesis . Data were collected during the hospital stay and telephone follow-ups were conducted at 30 days post procedure and annually thereafter . Patients were 80.9±4.4 years old with a mean logistic EuroSCORE I of 19.3±13.9 % . Transapical patients had significantly more comorbidities at baseline . Post intervention , mean gradient was reduced to 10.6±9.2 mmHg , and 1.9 % had moderate paravalvular regurgitation . Mean follow-up time , based on the last patient contact , was 217±188 days for the transfemoral and 525±413 days for the transapical group . Thirty-day mortality was 2.5 % and 4.0 % , and one-year Kaplan-Meier survival was 94.8 % ( 95 % CI : 87.5 - 97.9 ) and 81.9 % ( 95 % CI : 72.0 - 88.5 ) , respectively . At two years , survival was 64.9 % ( 95 % CI : 52.6 - 74.7 ) for transapical patients . CONCLUSIONS This early single-centre experience showed very good safety and performance outcomes in patients treated with the ACURATE prostheses Abstract OBJECTIVES : The ACURATE TATM system is a self-exp and ing transcatheter heart valve system design ed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials . The SAVI-1 and SAVI-2 registries aim ed to assess whether these promising outcomes can be translated into all-comers clinical routine . METHODS : From November 2011 to 2012 ( SAVI-1 ) , and November 2013 to 2014 ( SAVI-2 ) , a total of 500 patients were enrolled in the prospect i ve , all-comers , multicentre , multinational SAVI registries . Patients were treated according to the st and ard of care at their respective hospitals . We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2 . RESULTS : Patients were 80.8 ± 6.1 years old , the mean logistic EuroSCORE-I was 23.4 ± 14.3 % . Valves were deployed under rapid pacing in 71.3 % of the procedures in SAVI-1 , and in 3.6 % in SAVI- 
    Output:
    