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: OBJECTIVE Prospect i ve r and omised study comparing patients with atrial fibrillation ( AF ) of more than 6 months duration after mitral valve surgery plus biatrial modified radiofrequency Maze procedure using Medtronic Cardioblate System ( Cardioblate group , n=24 ) vs mitral valve surgery plus intensive rhythm control strategy ( control group , n=25 ) . METHODS Patients were blinded to r and omisation . Preoperatively , at discharge , and at 3-month and 1-year follow-up ,  echocardiography , quality of life assessment s and ECGs  were done . In both groups , sinus rhythm ( SR ) restoration was attempted by intra- and postoperative DC cardioversion and class III antiarrhythmic medication . All patients received warfarin . Amiodarone and warfarin was considered for discontinuation after 3 months in SR , 24-h Holter or event monitor excluding AF . RESULTS Both groups underwent mitral valve replacement or repair ( Cardioblate vs control : 16:8 vs 10:15 ) , had similar gender ( male : 33 % vs 56 % ) , age ( 66+/-8 years vs 68+/-9 years ) , additional aortic valve replacement ( 7 vs 6 patients ) , tricuspid annuloplasty ( 13 vs 13 patients ) , and CABG ( 10 vs 16 patients ) . There was 0 % operative mortality , 0 % postoperative cerebrovascular accidents , but 2 late deaths in the control group . At discharge , 3- and 12-month follow-up , more patients in the Cardioblate group returned to normal SR compared to control ( 29 % , 57 % and 75 % vs 20 % , 43 % and 39 % ; p=0.030 ) . Return of functional atrial contraction in patients in SR at 1 year was comparable between groups ( 63 % vs 89 % , NS ) , and more likely in non-rheumatic pathology and preoperative AF of shorter duration . The effectiveness of atrial contraction was 36+/-14 % vs 43+/-18 % of transmitral flow and there was no difference between groups .  Amiodarone treatment decreased more in Cardioblate group over time ( 92 % , 55 % and 29 % vs 52 % , 52 % and 21 % ; p=0.003 ) , whereas warfarin decrease was comparable ( 100 % , 100 % and 71 % vs 100 % , 95 % and 82 % ; NS ) . CONCLUSIONS Radiofrequency Maze ablation additional to mitral valve surgery result ed in a higher SR conversion rate ( 75 % ) , despite control group treatment with intensive rhythm control strategy having a higher SR conversion rate ( 39 % ) compared to literature ( approximately 25 % ) . Maze ablation result ed in normalisation of atrial function in 63 % of patients converted to SR OBJECTIVES Various modifications have been proposed to the original Cox 's Maze procedure due to concerns about the long bypass and cross clamp times . The efficacy of these procedures has been studied and reported . We conducted a r and omised prospect i ve study to compare three procedures , differing in extent , of ablation in patients in atrial fibrillation who were undergoing surgery for rheumatic valvular heart disease . These procedures utilised radiofrequency in the bipolar mode . The extent of ablation was ( 1 ) biatrial ( replication of the Cox Maze ) ( 2 ) left atrial portion of the Cox Maze and ( 3 ) pulmonary vein isolation along with a control group ( the No Maze group ) . Conversion rate to sinus rhythm was studied over a mid-term follow-up period . METHODS A total of 160 patients were studied with 40 patients in each group .  Antiarrhythmic drugs were not used in the three months preceding surgery and for seven days postoperatively . The patients underwent surgery for their valve disease along with the ablative procedure as per r and omisation using radiofrequency microbipolar coagulation and cryoablation . They were followed up and were evaluated for symptomatic improvement , rhythm with ECG documentation and 2D echocardiography . RESULTS Follow-up was available for 133 patients . Mid-term results showed that sinus rhythm was restored in 62.5 % patients of Biatrial Maze group and 57.5 % in the Left Atrial Maze . In the Pulmonary Vein Isolation Maze group , 67.5 % patients converted to NSR whereas in the No Maze group only 20 % patients were in sinus rhythm ( p value for all the groups was 0.001 when compared to the No Maze group ) . The incidence of other arrhythmias was not significant and there were no other major complications . All the patients in sinus rhythm at follow-up were in NYHA functional class I-II and showed good effort tolerance . CONCLUSIONS Results achieved with the three ablative procedures are comparable . Therefore lesser procedures viz . Left Atrial Maze and the Pulmonary Vein Isolation Maze procedures must be studied further with the additional use of antiarrhythmic drugs AIMS The efficacy of epicardial left atrial ( LA ) cryoablation in eliminating  atrial fibrillation ( AF ) in patients undergoing mitral valve surgery ( MVS ) is unknown . We hypothesized that MVS combined with LA cryoablation is superior to MVS alone . METHODS AND RESULTS Sixty-nine patients with permanent AF , included at four centres , underwent MVS with or without epicardial LA cryoablation . The primary endpoint was regained sinus rhythm . Risk factors for failed AF cryoablation were eluci date d. Sixty-five out of 69 patients reached the primary endpoint . At 6 and 12 months follow-up , 73.3 % of patients who underwent cryoablation had regained sinus rhythm at both follow-ups , compared with 45.7 and 42.9 % of patients , respectively , who underwent MVS alone ( group differences , at 6 months P = 0.024 , after 12 months P = 0.013 ) . The in-hospital complication rate was 11.4 % in the MVS group and 26.5 % in the cryoablation group ( P = 0.110 ) . Risk factors for failed elimination of AF by cryoablation were duration of permanent AF ( P = 0.012 ) and presence of coronary artery disease ( P = 0.047 ) , according to multiple logistic regression analysis . CONCLUSION This first prospect i ve r and omized study showed that combining MVS with epicardial LA cryoablation is significantly better in eliminating pre-operative permanent AF than MVS alone Background —Although the Cox-Maze III procedure is effective for treating permanent atrial fibrillation ( AF ) , its high complexity limits its use . The Saline-Irrigated Cooled-tip Radiofrequency Ablation ( SICTRA ) System is an alternative source of energy used to ablate AF . The aim of this study was to evaluate the effectiveness of the SICTRA for the treatment of permanent AF in patients with rheumatic mitral valve ( MV ) disease . Methods and Results —Between February 2002 and April 2003 , 70 patients with permanent AF and rheumatic MV disease were r and omly assigned to undergo a modified Maze III procedure using SICTRA associated with MV surgery ( group A ) or MV surgery alone ( group B ) . Groups A and B were similar in terms of baseline characteristics . The in-hospital mortality rate was 2.3 % ( 1 death ) in group A versus 0 % ( no deaths ) in group B ( P>0.99 ) . The additional time required for the left-sided radiofrequency ablation in group A was 14.2±5.1 minutes and for right-sided ablation was 12.3±4.2 minutes . The mean postoperative follow-up periods were 13.8±3.4 and 11.5±7.3 months , respectively , in groups A and B. The overall mid-term survival rate was 95.1 % in group A and 92.8 % in group B ( P>0.99 ) . The cumulative rates of sinus rhythm were 79.4 % in group A and 26.9 % in group B ( P=0.001 ) . Doppler echocardiography documented biatrial transport function in 90.3 % of group A patients in sinus rhythm . Conclusions —The SICTRA is effective for treating permanent AF associated with rheumatic MV disease OBJECTIVE Radiofrequency or the use of microwave energy in combination with atrial size reduction during open heart surgery have been reported to be effective in up to 75 % in the treatment of permanent atrial fibrillation . However , no data from prospect i ve r and omized trials using microwave energy are available . METHODS Forty-three patients with permanent atrial fibrillation undergoing open-heart surgery were r and omly stratified into treatment group receiving microwave ablation and atrial size reduction ( n=24 ) or control group ( n=19 ) . Patients in either group were treated with amiodarone or sotalol for 3 months if sinus rhythm or any atrioventricular rhythm was successfully restored . Follow-up time points were at 3 , 6 and 12 month after surgery . RESULTS In the treatment group 22 out of 24 patients ( 91,7 % ) were successfully converted to sinus rhythm by using intraoperative microwave ablation therapy whereas only six out of 19 ( 31.5 % ) patients converted to sinus rhythm directly after surgery . At 12-month follow-up there were still a significantly higher percentage of patients in the treatment group free from atrial fibrillation when compared to control ( 80 vs. 33.3 % , P=0.036 ) . CONCLUSION The preliminary data from this first prospect ively r and omized trial indicate that microwave ablation combined with atrial size reduction is a safe and highly efficient treatment in permanent atrial fibrillation We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11 AIMS Our aim was to compare the long-term effects on rhythm and quality of life ( QoL ) after left atrial epicardial radiofrequency ( RF ) ablation vs. no ablation in patients undergoing cardiac surgery . METHODS AND RESULTS Thirty-nine patients with ECG documented atrial fibrillation ( AF ) scheduled for coronary artery bypass grafting ( CABG ) with or without concomitant valve surgery were consecutively elected for epicardial RF ablation .  Thirty-nine age- and gender-matched patients scheduled for CABG with or without concomitant valve surgery only and with documented AF served as controls . The follow-up after ablation was 32 + /- 11 months . The percentage of patients in sinus rhythm ( SR ) at long-term follow-up was 62 vs. 33 % ( P = 0.03 ) after ablation and no ablation , respectively . SR at 3 months was highly predictive of that at 32 months ( sensitivity 95 % , positive predictive value 86 % ) . Long-term SR was associated with better QoL , fewer symptoms , higher ejection fraction , and smaller left and right atria than AF . CONCLUSION SR at 3 months was highly predictive of long-term SR that was associated with clinical improvement when compared with patients still in AF . AF at 3 months did not preclude a later stabilization to SR CONTEXT Although left atrial radiofrequency ablation ( RFA ) is increasingly used for the treatment of chronic atrial fibrillation during mitral valve surgery , its efficacy to restore sinus rhythm and any result ing benefits have not been examined in the context of an adequately powered r and omized trial . OBJECTIVE To determine whether intraoperative RFA of the left atrium increases the long-term restoration of sinus rhythm and improves exercise capacity . DESIGN , SETTING , AND PATIENTS R and omized , double-blind trial performed in a single UK tertiary referral center with enrollment between December 2001 and November 2003 . A total of 101 patients referred for mitral valve surgery with at least 6 months ' history of uninterrupted atrial fibrillation were assessed for eligibility ; 97 were enrolled . Patients were followed up for 12 months . INTERVENTION Patients were r and omly assigned to undergo mitral valve surgery and RFA of the left atrium ( n = 49 ) or mitral valve surgery alone ( controls ; n = 48 ) . MAIN OUTCOME MEASURES The primary outcome measure was presence of sinus rhythm at 12 months ; secondary measures were patient functional 
    Output:
    
agent
Results The consensus panel agreed on the following statements in patients with AF undergoing cardiac surgery concomitant surgical ablation : 1 .
Improves the achievement of sinus rhythm at discharge and 1 year ( level A ) ; this effect is sustained up to 5 years ( level B ) .
2 .
3 .
Does not increase the risk of perioperative mortality ( level A ) , stroke ( level A ) , myocardial infa rct ion ( level B ) , cardiac tamponade ( level A ) , reoperative bleeding ( level A ) , esophageal injury ( level B ) , low cardiac output ( level A ) , intraaortic balloon ( level B ) , congestive heart failure ( level B ) , ejection fraction ( EF ; level B ) , pleural effusion ( level A ) , pneumonia ( level A ) , renal dysfunction ( level B ) , and mediastinitis ( level A ) .
The incidence of esophageal injury remains to be low ( level B ) .
4 .
Does not reduce mortality at 1 year ( level A ) .
5 .
6 .
Increases cardiopulmonary bypass and cross-clamp times ( level A ) , with no difference in intensive care unit and hospital length of stay ( level A ) .
Conclusions Given these evidence -based statements , the consensus panel stated that , in patients with persistent and permanent AF undergoing cardiac surgery , concomitant surgical ablation is recommended to increase incidence of sinus rhythm at short- and long-term follow-up ( class 1 , level A ) ; to reduce the risk of stroke and thromboembolic events ( class 2a , level B ) ; to improve EF ( class 2a , level A ) ; and to exercise tolerance ( class 2a , level A ) and long-term survival ( class 2a , level B )
***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 Prospect i ve r and omised study comparing patients with atrial fibrillation ( AF ) of more than 6 months duration after mitral valve surgery plus biatrial modified radiofrequency Maze procedure using Medtronic Cardioblate System ( Cardioblate group , n=24 ) vs mitral valve surgery plus intensive rhythm control strategy ( control group , n=25 ) . METHODS Patients were blinded to r and omisation . Preoperatively , at discharge , and at 3-month and 1-year follow-up ,  echocardiography , quality of life assessment s and ECGs  were done . In both groups , sinus rhythm ( SR ) restoration was attempted by intra- and postoperative DC cardioversion and class III antiarrhythmic medication . All patients received warfarin . Amiodarone and warfarin was considered for discontinuation after 3 months in SR , 24-h Holter or event monitor excluding AF . RESULTS Both groups underwent mitral valve replacement or repair ( Cardioblate vs control : 16:8 vs 10:15 ) , had similar gender ( male : 33 % vs 56 % ) , age ( 66+/-8 years vs 68+/-9 years ) , additional aortic valve replacement ( 7 vs 6 patients ) , tricuspid annuloplasty ( 13 vs 13 patients ) , and CABG ( 10 vs 16 patients ) . There was 0 % operative mortality , 0 % postoperative cerebrovascular accidents , but 2 late deaths in the control group . At discharge , 3- and 12-month follow-up , more patients in the Cardioblate group returned to normal SR compared to control ( 29 % , 57 % and 75 % vs 20 % , 43 % and 39 % ; p=0.030 ) . Return of functional atrial contraction in patients in SR at 1 year was comparable between groups ( 63 % vs 89 % , NS ) , and more likely in non-rheumatic pathology and preoperative AF of shorter duration . The effectiveness of atrial contraction was 36+/-14 % vs 43+/-18 % of transmitral flow and there was no difference between groups .  Amiodarone treatment decreased more in Cardioblate group over time ( 92 % , 55 % and 29 % vs 52 % , 52 % and 21 % ; p=0.003 ) , whereas warfarin decrease was comparable ( 100 % , 100 % and 71 % vs 100 % , 95 % and 82 % ; NS ) . CONCLUSIONS Radiofrequency Maze ablation additional to mitral valve surgery result ed in a higher SR conversion rate ( 75 % ) , despite control group treatment with intensive rhythm control strategy having a higher SR conversion rate ( 39 % ) compared to literature ( approximately 25 % ) . Maze ablation result ed in normalisation of atrial function in 63 % of patients converted to SR OBJECTIVES Various modifications have been proposed to the original Cox 's Maze procedure due to concerns about the long bypass and cross clamp times . The efficacy of these procedures has been studied and reported . We conducted a r and omised prospect i ve study to compare three procedures , differing in extent , of ablation in patients in atrial fibrillation who were undergoing surgery for rheumatic valvular heart disease . These procedures utilised radiofrequency in the bipolar mode . The extent of ablation was ( 1 ) biatrial ( replication of the Cox Maze ) ( 2 ) left atrial portion of the Cox Maze and ( 3 ) pulmonary vein isolation along with a control group ( the No Maze group ) . Conversion rate to sinus rhythm was studied over a mid-term follow-up period . METHODS A total of 160 patients were studied with 40 patients in each group .  Antiarrhythmic drugs were not used in the three months preceding surgery and for seven days postoperatively . The patients underwent surgery for their valve disease along with the ablative procedure as per r and omisation using radiofrequency microbipolar coagulation and cryoablation . They were followed up and were evaluated for symptomatic improvement , rhythm with ECG documentation and 2D echocardiography . RESULTS Follow-up was available for 133 patients . Mid-term results showed that sinus rhythm was restored in 62.5 % patients of Biatrial Maze group and 57.5 % in the Left Atrial Maze . In the Pulmonary Vein Isolation Maze group , 67.5 % patients converted to NSR whereas in the No Maze group only 20 % patients were in sinus rhythm ( p value for all the groups was 0.001 when compared to the No Maze group ) . The incidence of other arrhythmias was not significant and there were no other major complications . All the patients in sinus rhythm at follow-up were in NYHA functional class I-II and showed good effort tolerance . CONCLUSIONS Results achieved with the three ablative procedures are comparable . Therefore lesser procedures viz . Left Atrial Maze and the Pulmonary Vein Isolation Maze procedures must be studied further with the additional use of antiarrhythmic drugs AIMS The efficacy of epicardial left atrial ( LA ) cryoablation in eliminating  atrial fibrillation ( AF ) in patients undergoing mitral valve surgery ( MVS ) is unknown . We hypothesized that MVS combined with LA cryoablation is superior to MVS alone . METHODS AND RESULTS Sixty-nine patients with permanent AF , included at four centres , underwent MVS with or without epicardial LA cryoablation . The primary endpoint was regained sinus rhythm . Risk factors for failed AF cryoablation were eluci date d. Sixty-five out of 69 patients reached the primary endpoint . At 6 and 12 months follow-up , 73.3 % of patients who underwent cryoablation had regained sinus rhythm at both follow-ups , compared with 45.7 and 42.9 % of patients , respectively , who underwent MVS alone ( group differences , at 6 months P = 0.024 , after 12 months P = 0.013 ) . The in-hospital complication rate was 11.4 % in the MVS group and 26.5 % in the cryoablation group ( P = 0.110 ) . Risk factors for failed elimination of AF by cryoablation were duration of permanent AF ( P = 0.012 ) and presence of coronary artery disease ( P = 0.047 ) , according to multiple logistic regression analysis . CONCLUSION This first prospect i ve r and omized study showed that combining MVS with epicardial LA cryoablation is significantly better in eliminating pre-operative permanent AF than MVS alone Background —Although the Cox-Maze III procedure is effective for treating permanent atrial fibrillation ( AF ) , its high complexity limits its use . The Saline-Irrigated Cooled-tip Radiofrequency Ablation ( SICTRA ) System is an alternative source of energy used to ablate AF . The aim of this study was to evaluate the effectiveness of the SICTRA for the treatment of permanent AF in patients with rheumatic mitral valve ( MV ) disease . Methods and Results —Between February 2002 and April 2003 , 70 patients with permanent AF and rheumatic MV disease were r and omly assigned to undergo a modified Maze III procedure using SICTRA associated with MV surgery ( group A ) or MV surgery alone ( group B ) . Groups A and B were similar in terms of baseline characteristics . The in-hospital mortality rate was 2.3 % ( 1 death ) in group A versus 0 % ( no deaths ) in group B ( P>0.99 ) . The additional time required for the left-sided radiofrequency ablation in group A was 14.2±5.1 minutes and for right-sided ablation was 12.3±4.2 minutes . The mean postoperative follow-up periods were 13.8±3.4 and 11.5±7.3 months , respectively , in groups A and B. The overall mid-term survival rate was 95.1 % in group A and 92.8 % in group B ( P>0.99 ) . The cumulative rates of sinus rhythm were 79.4 % in group A and 26.9 % in group B ( P=0.001 ) . Doppler echocardiography documented biatrial transport function in 90.3 % of group A patients in sinus rhythm . Conclusions —The SICTRA is effective for treating permanent AF associated with rheumatic MV disease OBJECTIVE Radiofrequency or the use of microwave energy in combination with atrial size reduction during open heart surgery have been reported to be effective in up to 75 % in the treatment of permanent atrial fibrillation . However , no data from prospect i ve r and omized trials using microwave energy are available . METHODS Forty-three patients with permanent atrial fibrillation undergoing open-heart surgery were r and omly stratified into treatment group receiving microwave ablation and atrial size reduction ( n=24 ) or control group ( n=19 ) . Patients in either group were treated with amiodarone or sotalol for 3 months if sinus rhythm or any atrioventricular rhythm was successfully restored . Follow-up time points were at 3 , 6 and 12 month after surgery . RESULTS In the treatment group 22 out of 24 patients ( 91,7 % ) were successfully converted to sinus rhythm by using intraoperative microwave ablation therapy whereas only six out of 19 ( 31.5 % ) patients converted to sinus rhythm directly after surgery . At 12-month follow-up there were still a significantly higher percentage of patients in the treatment group free from atrial fibrillation when compared to control ( 80 vs. 33.3 % , P=0.036 ) . CONCLUSION The preliminary data from this first prospect ively r and omized trial indicate that microwave ablation combined with atrial size reduction is a safe and highly efficient treatment in permanent atrial fibrillation We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11 AIMS Our aim was to compare the long-term effects on rhythm and quality of life ( QoL ) after left atrial epicardial radiofrequency ( RF ) ablation vs. no ablation in patients undergoing cardiac surgery . METHODS AND RESULTS Thirty-nine patients with ECG documented atrial fibrillation ( AF ) scheduled for coronary artery bypass grafting ( CABG ) with or without concomitant valve surgery were consecutively elected for epicardial RF ablation .  Thirty-nine age- and gender-matched patients scheduled for CABG with or without concomitant valve surgery only and with documented AF served as controls . The follow-up after ablation was 32 + /- 11 months . The percentage of patients in sinus rhythm ( SR ) at long-term follow-up was 62 vs. 33 % ( P = 0.03 ) after ablation and no ablation , respectively . SR at 3 months was highly predictive of that at 32 months ( sensitivity 95 % , positive predictive value 86 % ) . Long-term SR was associated with better QoL , fewer symptoms , higher ejection fraction , and smaller left and right atria than AF . CONCLUSION SR at 3 months was highly predictive of long-term SR that was associated with clinical improvement when compared with patients still in AF . AF at 3 months did not preclude a later stabilization to SR CONTEXT Although left atrial radiofrequency ablation ( RFA ) is increasingly used for the treatment of chronic atrial fibrillation during mitral valve surgery , its efficacy to restore sinus rhythm and any result ing benefits have not been examined in the context of an adequately powered r and omized trial . OBJECTIVE To determine whether intraoperative RFA of the left atrium increases the long-term restoration of sinus rhythm and improves exercise capacity . DESIGN , SETTING , AND PATIENTS R and omized , double-blind trial performed in a single UK tertiary referral center with enrollment between December 2001 and November 2003 . A total of 101 patients referred for mitral valve surgery with at least 6 months ' history of uninterrupted atrial fibrillation were assessed for eligibility ; 97 were enrolled . Patients were followed up for 12 months . INTERVENTION Patients were r and omly assigned to undergo mitral valve surgery and RFA of the left atrium ( n = 49 ) or mitral valve surgery alone ( controls ; n = 48 ) . MAIN OUTCOME MEASURES The primary outcome measure was presence of sinus rhythm at 12 months ; secondary measures were patient functional 
    Output:
    