Ventricular arrhythmias in aortic valve stenosis before and after transcatheter aortic valve implantation. Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System. Transcatheter aortic valve implantation in lower-risk patients: what is the perspective? Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial. Registry of transcatheter aortic-valve implantation in high-risk patients. Incidence rate and predictors of permanent pacemaker implantation after transcatheter aortic valve implantation with self-expanding CoreValve prosthesis Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: Analysis from the german transcatheter aortic valve interventions registry Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registry. Impact of previous cardiac operations on patients undergoing transapical aortic valve implantation: results from the Italian Registry of Transapical Aortic Valve Implantation. Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve Incidence, predictive factors, and prognostic value of new-onset atrial fibrillation following transcatheter aortic valve implantation. Electrocardiographic Predictors of Long‐Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation Preserved prognostic value of preinterventional troponin T levels despite successful TAVI in patients with severe aortic stenosis Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes. A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population Temporal changes of new-onset atrial fibrillation in patients randomized to surgical or transcatheter aortic valve replacement.
AIMS Transcatheter aortic valve implantation ( TAVI ) is a therapeutic treatment for patients with severe aortic stenosis ( AS ) at high surgical risk . Although the procedure is associated with a reduction in total mortality , there are no data regarding changing in the incidence of premature ventricular contractions ( PVCs ) and ventricular arrhythmias ( VAs ) after TAVI . The aim of this study was to assess the incidence of VAs before and after TAVI . METHODS AND RESULTS We enrolled 237 patients who underwent TAVI at our centre . Ninety-one patients were excluded for the following reasons : presence of prior permanent pacemaker ( PPM ) ( n = 20 ) , new PPM implant after TAVI ( n = 48 ) , death during the follow-up period ( n = 16 ) , and lost at follow-up ( n = 7 ) . Finally , 146 patients were included in our analysis . The presence of VAs was evaluated in all patients recording a 24 h Holter monitoring before the procedure and after 1 and 12 months . Ventricular arrhythmias were classified according to a modified Lown grading system . Before the procedure , isolates PVCs ( grade 1 - 2 of Lown grading system ) were present in 34.9 % of patients ( n = 51 ) . Complex PVCs ( grade 3 - 4a-4b of Lown grading system ) were present in 48.6 % of the population ( multifocal PVCs in 32 patients , 21.9 % ; pairs in 25 patients , 17.1 % ; ventricular tachycardia in 14 patients , 9.6 % ) . One month after the procedure , we observed statistically significant incidence decrease of arrhythmias of grade 3 ( from 21.9 to 17.1 % ) and grade 4 ( pairs from 17.1 to 12.3 % ; ventricular tachycardia from 9.6 to 4.8 % ) . After 12 months , there was a further significant reduction in the frequency and severity of PVCs . In particular , 45.8 % of patients had isolates PVCs ( < 30 in all given hours of monitoring in 45 patients , 30.8 % ; higher than 30 in any hour of monitoring in 22 patients , 15 % ) while the frequency of complex arrhythmias was reduced to 16.4 % ( multifocal PVCs in 13 patients , 9 % ; couplets 8 patients , 5.5 % and ventricular tachycardia in 3 patients , 2.0 % ) . The difference was statistically significant ( P < 0.01 ) . CONCLUSION This study indicates that VAs are common in patients with AS . We observed a significant decrease in the incidence and severity of PVCs since the first month after TAVI . Furthermore , after 1 year follow-up there was a further and significant reduction in the frequency of complex PVCs . This may be related to the benefits determined by valve replacement on left ventricular function BACKGROUND / OBJECTIVES To determine pacemaker ( PM ) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation ( PPI ) following transcatheter aortic valve implantation ( TAVI ) .  METHODS Single center prospect i ve observational study including 167 patients without previous PM implantation who underwent TAVI with the self-exp and ing Medtronic CoreValve System ( MCS ) between November 2005 and February 2011 . PM dependency was defined by the presence of a high degree atrioventricular block ( HDAVB ; second [ AV2 ] and third degree [ AV3B ] ) , or a slow ( < 30 bpm ) or absent ventricular escape rhythm during follow-up PM interrogation . RESULTS A total of 36 patients ( 21.6 % ) received a new PM following TAVI . The indication for PM was AV2B ( n=2 , 5.6 % ) , AV3B ( n=28 , 77.8 % ) , postoperative symptomatic bradycardia ( n=3 , 8.3 % ) , brady-tachy syndrome ( n=1 , 2.8 % ) , atrial fibrilation with slow response ( n=1 , 2.8 % ) and left bundle branch block ( n=1 , 2.8 % ) . Long term follow-up was complete for all patients and ranged from 1 to 40 months ( median ( IQR ) : 11.5 ( 5.0 - 18.0 months ) . Of those patients with a HDAVB , 16 out of the 30 patients ( 53.3 % ) were PM independent at follow-up visit ( complete or partial resolution of the AV conduction abnormality ) . Overall , 20 out of the 36 patients ( 55.6 % ) who received a new PM following TAVI were PM independent at follow-up . CONCLUSION Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients In the last decade , transcatheter aortic valve implantation ( TAVI ) , a disruptive technology , has revolutionized the therapy of symptomatic severe aortic stenosis , and current guidelines state that the recommendations for TAVI and surgical aortic valve replacement ( SAVR ) are equivalent in patients at high-risk . Increased operator experience , technical advances in the new generation of transcatheter heart valves ( THV ) and excellent TAVI results in recently published r and omized controlled trials have led to the expansion of TAVI indication as an alternative to SAVR in intermediate-risk subjects , given appropriate patient selection . The time is opportune to examine the role of TAVI in low-risk patients , currently the objective of on-going r and omized trials . This review aims to summarize the available knowledge on TAVI in low- to intermediate-risk patients and to discuss the potential advantages and pitfalls TAVI will face in this clinical setting 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 AIMS In a prospect i ve r and omised trial we aim ed to compare transapical transcatheter aortic valve implantation ( a-TAVI ) with surgical aortic valve replacement ( SAVR ) in operable elderly patients . METHODS AND RESULTS The study was design ed as a r and omised controlled trial of a-TAVI ( Edwards SAPIEN heart valve system ; Edwards Lifesciences , Irvine , CA , USA ) vs. SAVR .  Operable patients with isolated aortic valve stenosis and an age ≥75 years were included . The primary endpoint was the composite of all-cause mortality , cerebral stroke and /or renal failure requiring haemodialysis at 30 days . After advice from the Data Safety Monitoring Board , the study was prematurely terminated after the inclusion of 70 patients because of an excess of events in the a-TAVI  group . The primary endpoint was met in five a-TAVI patients ( two deaths , two strokes , and one case of renal failure requiring dialysis ) vs. one stroke in the SAVR group ( p=0.07 ) . In the a-TAVI group , one patient was converted to SAVR because of an abnormally positioned heart , and four patients were re-operated with open heart surgery because of annulus rupture ( n=1 ) , severe paravalvular leakage ( n=2 ) , and blockage of the left coronary artery ( n=1 ) . In the SAVR group , one patient was converted to TAVI because of a large intra-thoracic goitre . CONCLUSIONS Given the limitations of a small prematurely terminated study , our results suggest that a-TAVI in its present form may be associated with complications and device success rates in low-risk patients similar or even inferior to those found in high-risk patients with aortic valve stenosis . This will probably change in the near future with improved catheter based devices and better pre-procedural assessment 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 . ) Background Conduction disorders and permanent pacemaker ( PPM ) implantation are common complications in patients undergoing transcatheter aortic valve implantation ( TAVI ) .  Previous studies , evaluating small population s , have identified several different predictors of PPM implantation after TAVI . The aim of this study was to assess the incidence rate of conduction disorders and the predictors of postoperative PPM requirement in a large series of patients undergoing TAVI .  Methods Data were analyzed from 181 consecutive patients at high-risk surgery who underwent TAVI at our institute between July 2007 and April 2011 . All patients underwent implantation of the third-generation percutaneous self-exp and ing CoreValve ® prosthesis  ( CoreValve , Inc. , Irvine , CA , USA ) . In all patients , a  12-lead electrocardiogram and a  24-h holter monitoring  was recorded before and after the procedure in order to assess the presence of conduction disorders . Clinical data , preoperative conduction disorders , echocardiographic patterns , and procedural data were tested as predictors of PPM implantation after TAVI . Results Left bundle branch block ( LBBB ) was the most common conduction disorder , with an incidence of 50.3 % at discharge . Fifty-two ( 32.1 % ) patients developed a persistent complete AVB requiring PPM implantation . PPM implantation was strongly correlated with the presence of preoperative right bundle branch block ( RBBB ) which was found to be the only independent predictor of PPM implantation ( HR 16.5 , CI 3.3–82.3 , p < 0.001 ) . Conclusions LBBB and PPM implantation requirement after TAVI are common occurrences using the self-exp and ing CoreValve prosthesis . In this large series of consecutive patients , only RBBB was found to be a strong predictor of PPM requirement To determine predictors of  permanent pacemaker ( PPM ) implantation  up to 30 days after transcatheter aortic valve implantation ( TAVI )  in a prospect i ve multicenter registry AIMS To evaluate short-term clinical outcomes following  transcatheter aortic valve implantation ( TAVI )  using CE-mark approved devices in Switzerl and . METHODS AND RESULTS The Swiss TAVI  registry is a national , prospect i ve , multicentre , monitored cohort study evaluating clinical outcomes in consecutive patients undergoing TAVI at cardiovascular centres in Switzerl and . From February 2011 to March 2013 , a total of 697 patients underwent TAVI for native aortic valve stenosis ( 98.1 % ) , degenerative aortic bioprosthesis ( 1.6 % ) or severe aortic regurgitation ( 0.3 % ) . Patients were elderly ( 82.4±6 years ) , 52 % were females , and the majority highly symptomatic ( 73.1 % NYHA III/IV ) . Patients with severe aortic stenosis ( mean gradient 44.8±17 mmHg , aortic valve area 0.7±0.3 cm² ) were either deemed inoperable or at high risk for conventional surgery ( STS 8.2%±7 ) . The transfemoral access was the most frequently used ( 79.1 % ) , followed by transapical ( 18.1 % ) , direct aortic ( 1.7 % ) and subclavian access ( 1.1 % ) . At 30 days , rates of all-cause mortality , cerebrovascular events and myocardial infa rct ion were 4.8 % , 3.3 % and 0.4 % , respectively . The most frequently observed adverse events were access-related complications ( 11.8 % ) , permanent pacemaker implantation ( 20.5 % ) and bleeding complications ( 16.6 % ) . The Swiss TAVI registry is registered at Clinical Trials.gov ( NCT01368250 ) . CONCLUSIONS The Swiss TAVI registry is a national cohort study evaluating consecutive TAVI procedures in Switzerl and . This first outcome report provides favourable short-term clinical outcomes in unselected TAVI patients OBJECTIVES Redo cardiac surgery has an increased risk of morbidity and mortality when compared with the initial operation . The aim of this study was to assess the impact of previous cardiac operations on patients undergoing transapical aortic valve implantation ( TA-TAVI ) .  METHODS We analysed data from 566 patients included in the Italian Registry of Transapical Aortic Valve Implantation who underwent TA-TAVI implantation with the Sapien valve ( Edwards Lifesciences , Irvine , CA , USA ) from April 2008 through May 2011 . Of these , 110 patients ( 19.4 % ) had already undergone at least one previous cardiac operation with opening of the pericardium ( group R ) while for 456 patients ( 80.6 % ) TA-TAVI was the first cardiac procedure ( group F ) . Data were prospect ively collected at each of the 20 participating centres and then sent to a central data base for storage and analysis . RESULTS Preoperative logistic EuroSCORE was higher in group R ( 35 ± 18.6 vs. 23.5 ± 11.9 % ; P < 0.001 ) . Hospital mortality occurred in eight ( 7.2 % ) and 36 ( 7.9 % ) patients in groups R and F , respectively ( P = 0.8 ) . Mean follow-up was 10.4 ± 7.9 months ( range : 1 - 34 ) . Overall 2-year Kaplan-Meier survival was 64.2 ± 9.8 and 75.4 ± 3.5 % in groups R and F , respectively ( P = 0.69 ) . Incidence of operative complications , postoperative bleeding , pacemaker implantation , myocardial infa rct ion and stroke did not show statistically significant differences between groups . The univariate analysis showed that arterial hypertension , logistic EuroSCORE , porcelain aorta , left ventricular ejection fraction and previous percutaneous coronary interventions were significantly associated with 30-day mortality in group R. CONCLUSIONS According to our data , patients undergoing TAVI with previous cardiac operations have a higher preoperative risk profile but have similar outcomes when compared with patients undergoing a first operation . In these subset of patients , TAVI is a promising therapeutic option Background Predictors for the need of  permanent pacemaker implantation  ( PPMI ) in the context of transcatheter aortic valve implantation ( TAVI ) are not well defined yet . We evaluated the impact of conduction disturbances , calcium volume of the device l and ing zone , oversizing and implantation depth on PPMI after TAVI with the balloon-exp and able Edwards Sapien 3 ( ES3 ) . Methods and results 335 consecutive patients undergoing transfemoral TAVI with the ES3 for the treatment of symptomatic severe aortic stenosis were included ( clinical trials NCT02162069 ) . Rate of PPMI after TAVI was 18.4 % , excluding patients with permanent pacemakers prior to TAVI or valve-in-valve implantations . Patients requiring PPMI more often had first degree atrioventricular block ( AVB ) at baseline ( 48.7 vs. 16.5 % , p < 0.01 ) , preprocedural complete right bundle branch block ( RBBB ; 25.0 vs. 3.9 % , p < 0.01 ) and higher calcium volume of the aortic valve ( 258.5 ± 317.3 vs. 163.6 ± 178.8 mm³ , p < 0.01 ) . There was a trend towards higher rate of PPMI in patients with new-onset left bundle branch block after TAVI ( 32.7 vs. 20.7 % , p = 0.06 ) . Multivariate logistic regression analysis showed that baseline first degree AVB ( odds ratio 3.9 , 95 % confidence interval 1.73–9.10 , p < 0.01 ) and preprocedural complete RBBB ( odds ratio 4.5 , 95 % confidence interval 1.50–13.21 , p < 0.01 ) were independent predictors of PPMI . Of note , neither oversizing nor implantation depth were independent predictors for need of PPMI with the ES3 . Conclusions In patients treated with the ES3 for symptomatic severe aortic stenosis first degree AVB and complete RBBB at baseline were independently associated with higher rates of postprocedural PPMI , whereas implantation depth and oversizing did not have an impact on PPMI 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 Background Conduction disorders requiring permanent pacemaker ( PPM ) implantation are a known complication of transcatheter aortic valve implantation ( TAVI ) . Indications for permanent pacing in this setting are still controversial . The study aim was to characterize the natural history of conduction disorders related to TAVI , and to identify predictors for long‐term pacing dependency . Methods Consecutive patients who underwent TAVI  were included in this prospect i ve observational study . The conduction system was investigated by review ing 12‐lead ECGs during hospitalization and up to 1‐year follow‐up and by analyzing pacemaker interrogation data . Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency . Results Of 110 patients included in the analysis , 38 ( 34.5 % ) underwent PPM implantation . Of those , 26 ( 68.4 % ) had a long‐term pacing dependency ( required PPM ) , while 12 ( 31.6 % ) did not ( not‐required PPM ) . Logistic regression revealed that baseline RBBB ( P = 0.01 , OR = 18.0 ) , baseline PR interval ( P = 0.019 , OR = 1.14 ) , post‐TAVI PR interval and the change in PR interval from baseline ( P < 0.001 for both , OR = 1.17 for each 10 milliseconds increment ) were independent predictors for long‐term pacing dependency . A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency . Conclusions Increased pre‐ and postprocedural PR intervals and pre‐existing RBBB are reliable predictors for long‐term PPM dependency , while left bundle branch block or QRS width are misleading factors . Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval Background Elevated concentrations of troponin T have prognostic impact in patients with various cardiovascular diseases including those with severe aortic stenosis .  Transcatheter aortic valve implantation ( TAVI ) has improved prognosis for patients without a surgical option . Whether this affects the prognostic value of preinterventional troponin T remains unclear . Methods We therefore conducted a prospect i ve study in 198 consecutive patients with subsequent , successful transfemoral TAVI  and analyzed cardiac troponin T ( cTnT ) levels with a new generation , high-sensitive troponin T assay before and after TAVI , as well as their prognostic value after 12 months . Results Patients with severe aortic stenosis ( AS ) showed significant elevation of preinterventional cTnT levels . Postinterventional cTnT levels significantly rose further about sevenfold after transfemoral TAVI and peaked at day three until they steadily declined thereafter . Baseline renal function ( P = 0.011 ) , the duration of intraprocedural rapid pacing ( P = 0.0012 ) , and baseline cTnT ( P = 0.0001 ) values predicted the magnitude of postinterventional cTnT elevations . Interestingly , Kaplan – Meier curve analysis revealed , that although cTnT levels were not predictive for short-term mortality , preinterventional as well as postinterventional peak cTnT showed prognostic value for 1-year mortality , regardless of successful TAVI . Conclusions Pre- and postinterventional hscTnT levels signal adverse 1-year mortality in patients with severe AS independent of successful aortic valve replacement 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 Patients with severe aortic stenosis and coexisting non-cardiac conditions may be at high risk for surgical replacement of the aortic valve or even be no c and i date s for surgery . In these patients , transcatheter aortic valve implantation ( TAVI ) is suggested as an alternative . Results of the PARTNER ( Placement of AoRTic TraNscathetER Valve ) trial comparing the clinical effectiveness of TAVI with surgical valve replacement and st and ard therapy were published . The authors assessed the cost-effectiveness of TAVI  in Belgium . Methods A Markov model of incremental costs , effects ( survival and quality of life ) and incremental cost-effectiveness of TAVI was developed . The impact on survival , number of events and quality of life was based on the PARTNER trial . Costs per event were context specific . Results In high-risk operable patients , even if the minor differences in 30-day and 1-year mortality are taken into account , the incremental cost-effectiveness ratio ( ICER ) remains on average above € 750 000 per quality -adjusted life-year ( QALY ) gained ( incremental cost : € 20 400 ; incremental effect : 0.03 QALYs ) . In inoperable patients , an ICER of € 44 900 per QALY ( incremental cost : € 33 200 ; incremental effect : 0.74 QALYs ) is calculated , including a life-long extrapolation of the mortality benefit . This result was sensitive to the assumed time horizon . The subgroup of anatomically inoperable patients had better outcomes than medically inoperable patients , with ICERs decreasing more than € 10 000/QALY . Conclusions It is inappropriate to consider reimbursement of TAVI for high-risk operable patients . Reimbursing TAVI in inoperable patients in essence is a political decision . From an economic perspective , it would be prudent to first target patients that are inoperable because of anatomical prohibitive conditions . In the search for evidence , the authors identified non-published negative results from a r and omised controlled TAVI trial . The study sponsor should be more willing to share this information to allow balanced evaluations and policy recommendations . Payers should require these data before taking reimbursement decisions BACKGROUND Temporal development of new-onset atrial fibrillation ( NOAF ) after aortic valve replacement is unclear , and opportunistic screening has limited diagnostic accuracy . This is the first study to investigate the incidence and temporal development of NOAF detected by implantable loop recorder ( ILR ) in patients with aortic stenosis , r and omized to surgical aortic valve replacement ( SAVR ) or transcatheter aortic valve replacement ( TAVR ) . METHOD An ILR was implanted in a subgroup of patients without pre-procedural atrial fibrillation ( AF ) , r and omized to SAVR or TAVR in the NOTION trial . Data from the ILR were transmitted in intervals of 2weeks for 12weeks post-procedurally and analyzed . RESULTS The study included 25 and 27 patients who underwent SAVR and TAVR , respectively . The cumulative rate of NOAF was 100 % and 81.5 % for patients undergoing SAVR and TAVR , respectively ( P=0.06 ) . TAVR patients without NOAF 6weeks post-procedurally remained free from NOAF . The prevalence of AF after SAVR decreased significantly after 8weeks when compared with the first 2weeks ( 50.0 % vs. 84.0 % , respectively ; P<0.05 ) . The prevalence of AF after TAVR did not change significantly during follow-up . The median AF burden ( percentage of time with AF ) was 2.8 % and 0.04 % during the first 2weeks after SAVR and TAVR , respectively ( P=0.01 ) and it decreased significantly over time after SAVR but not after TAVR . CONCLUSION NOAF subsided 6weeks after TAVR . AF prevalence and burden decreased significantly over time after SAVR , but remained stable after TAVR . These findings may be considered for post-procedural anti-coagulation strategy
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
Objective To evaluate the prevalence and clinical impact of new-onset arrhythmias in patients following transcatheter aortic valve implantation ( TAVI ) .