Transcatheter aortic valve implantation in lower-risk patients: what is the perspective? Ventricular arrhythmias in aortic valve stenosis before and after transcatheter aortic valve implantation. Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: Analysis from the german transcatheter aortic valve interventions registry Transcatheter versus Surgical Aortic Valve Replacement in High-risk Patients: A propensity-score matched analysis. 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. Osteopontin predicts clinical outcome in patients after treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) Aortic valve stenosis after previous coronary bypass: Transcatheter valve implantation or aortic valve replacement? Coronary Artery Disease and Symptomatic Severe Aortic Valve Stenosis: Clinical Outcomes after Transcatheter Aortic Valve Implantation Registry of transcatheter aortic-valve implantation in high-risk patients. Multimodal assessment of the aortic annulus diameter: implications for transcatheter aortic valve implantation. Prevalence and prognostic implications of baseline anaemia in patients undergoing transcatheter aortic valve implantation. Early and mid-term outcomes in patients undergoing transcatheter aortic valve implantation after previous coronary artery bypass grafting. Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registry. Incidence, predictive factors, and prognostic value of new-onset atrial fibrillation following transcatheter aortic valve implantation. Comparison of effectiveness and safety of transcatheter aortic valve implantation in patients aged ≥90 years versus <90 years. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. The cost-effectiveness of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis at high operative risk Ongoing requirement for pacing post-transcatheter aortic valve implantation and surgical aortic valve replacement. The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: results from the German Transcatheter Aortic Valve Interventions Registry. Insights into the need for permanent pacemaker following implantation of the repositionable LOTUS valve for transcatheter aortic valve replacement in 250 patients: results from the REPRISE II trial with extended cohort. Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System. Long-term effect of exercise training in patients after transcatheter aortic valve implantation: Follow-up of the SPORT:TAVI randomised pilot study
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 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 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 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 BACKGROUND There is limited data from Australia and New Zeal and comparing transcatheter aortic valve implantation ( TAVI ) with conventional surgical aortic valve replacement ( sAVR ) . METHODS Between 2009 and 2015 , 64 patients underwent TAVI and 669 underwent sAVR at a single centre . Patients ' peri-operative details were analysed and compared between groups . Propensity-score matching was performed for risk adjustment . RESULTS Patients receiving TAVI were older ( mean age in years TAVI : 83.9±4.6 vs. sAVR : 71±9.9 , P<0.001 ) , and were more likely to be female  ( TAVI : 67 % , 43/64 , vs. sAVR : 32 % , 217/669 , P < 0.001 ) . Unadjusted 30-day mortality was comparable between groups ( 2/64 , 3 % vs. 22/669 , 3 % , P > 0.99 ) . The matched analysis revealed comparable 30-day mortality  ( TAVI : 2/44 , 5 % vs. sAVR : 2/44 , 5 % , P > 0.99 ) . New atrial arrhythmia occurred more frequently within the sAVR cohort ( TAVI : 1/44 , 2 % vs. sAVR 18/44 , 41 % , P < 0.001 ) . Complete heart block requiring permanent pacemaker was more frequent amongst the TAVI cohort ( TAVI : 10/44 , 23 % vs. sAVR 2/44 , 5 % , P=0.039 ) . At two years , survival was comparable between groups ( TAVI : 74±1.7 vs. sAVR : 80±0.1 % , P=0.65 ) . CONCLUSION This single centre experience suggests that TAVI is a valuable treatment option for high-risk surgical patients with comparable survival 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 Objective  Osteopontin ( OPN ) is an extracellular matrix protein that plays an integral role in myocardial remodelling and has previously been shown to be a valuable biomarker in cardiovascular disease . Because of the concentric myocardial hypertrophy associated with severe , symptomatic aortic stenosis ( AS ) , we hypothesised that OPN expression may have a prognostic value in patients undergoing transcatheter aortic valve implantation ( TAVI ) .  Methods We prospect ively included 217 patients undergoing TAVI between February 2011 and December 2013 with a median follow-up of 349 days . Twenty healthy individuals from the same age range free from structural heart disease served as controls . The primary endpoint for the analysis was survival time . Results Median preprocedural OPN levels ( 675 ng/mL ; IQR 488.5–990.5 ng/mL ) were significantly higher in patients with severe aortic valve stenosis compared with healthy controls ( 386 ng/mL ; IQR 324.5–458 , p<0.001 ) . Patients with increased OPN values showed at baseline a decreased 6 min walk test performance , increased rates of atrial arrhythmia , and an increased risk of death during follow-up ( HR 2.2 ; 95 % CI 1.3 to 3.5 for the comparison of the highest vs lowest OPN quartile ) . Multiple Cox regression analysis demonstrated that OPN improves the prediction of an adverse prognosis further than N-terminal probrain natriuretic peptide . Conclusions  OPN levels at baseline are associated with adverse outcomes in patients with severe , symptomatic AS undergoing TAVI We report a prospect i ve comparison between  transcatheter valve implantation ( TAVI , n = 13 ) and surgical aortic valve replacement ( AVR , n = 10 ) in patients with severe aortic valve stenosis and previous coronary bypass surgery ( CABG ) . All patients had at least bilateral patent internal thoracic arteries bypass without indication of repeat revascularization . After a similar post-procedure outcome , despite one early death in TAVI group , the 1-year survival was 100 % in surgical group and in transfemoral TAVI group , and 73 % in transapical TAVI group . When previous CABG is the lone surgical risk factor , indications for a TAVI procedure have to be cautious , specially if transfemoral approach is not possible Introduction The impact of coronary artery disease ( CAD ) on outcomes after transcatheter aortic valve implantation ( TAVI ) has not been clarified . Furthermore , less is known about the indication and strategy of revascularization in these high risk patients . Aims This study sought to determine the prevalence and prognostic impact of CAD in patients undergoing TAVI  , and to assess the safety and feasibility of percutaneous coronary intervention ( PCI ) before TAVI . Methods Patients with severe aortic stenosis ( AS ) undergoing TAVI were included into a prospect i ve single center registry from 2007 to 2012 . Clinical outcomes were compared between patients with and without CAD . In some patients with CAD , it was decided to perform elective PCI before TAVI after decision by the Heart team . The primary endpoints were 30-day and 2-year all-cause mortality . Results A total of 91 consecutive patients with mean age of 79 ± 9 years ( 52 % men )  underwent TAVI with a median follow-up duration of 16 months ( interquartile range of 27.6 months ) . CAD was present on 46 patients ( 51 % ) . At 30-day , the incidences of death were similar between CAD and non-CAD patients ( 9 and 5 % , p = 0.44 ) , but at 2 years were 50 % in CAD patients and 24 % in non-CAD patients [ crude hazard ratio with CAD , 2.2 ; 95 % confidence interval ( CI ) , 1.1–4.6 ; p = 0.04 ] . Adjusting for age , gender , left ventricular ejection fraction , and glomerular filtration rate , the hazard of death was 2.6-fold higher in patients with CAD ( 95 % CI , 1.1–6.0 ; p = 0.03 ) . Elective PCI before TAVI was performed in 13 patients ( 28 % of CAD patients ) . There were no more adverse events in patients who underwent TAVI + PCI when compared with those who underwent isolated TAVI . Conclusion In severe symptomatic AS who underwent TAVI  , CAD is frequent and adversely impacts long-term outcomes , but not procedure outcomes . In selected patients  , PCI before TAVI appears to be feasible and safe 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 . ) OBJECTIVES We sought to compare 3 methods of measurements of the aortic annulus , transthoracic echocardiography ( TTE ) , transesophageal echocardiography ( TEE ) , and multislice computed tomography ( MSCT ) , and to evaluate their potential clinical impact on transcatheter aortic valve implantation ( TAVI ) strategy . BACKGROUND Exact measurement of the aortic annulus is critical for a patient 's selection and successful implantation . METHODS Annulus diameter was measured using TTE , TEE , and MSCT in 45 consecutive patients with severe aortic stenosis referred for TAVI .  The TAVI strategy ( decision to implant and choice of the prosthesis ' size ) was based on manufacturer 's recommendations ( Edwards-Sapien prosthesis , Edwards Lifesciences , Inc. , Irvine , California ) . RESULTS Correlations between methods were good but the difference between MSCT and TTE ( 1.22 + /- 1.3 mm ) or TEE ( 1.52 + /- 1.1 mm ) was larger than the difference between TTE and TEE ( 0.6 + /- 0.8 mm ; p = 0.03 and p < 0.0001 , respectively ) . Regarding TAVI strategy , agreement between TTE and TEE overall was good ( kappa = 0.68 ) , but TAVI strategy would have been different in 8 patients ( 17 % ) . Agreement between MSCT and TTE or TEE was only modest ( kappa = 0.28 and 0.27 ) , and a decision based on MSCT measurements would have modified the TAVI strategy in a large number of patients ( 40 % to 42 % ) . Implantation , performed in 34 patients ( 76 % ) based on TEE measurements , was successful in all but 1 patient with grade 3/4 regurgitation . CONCLUSIONS In patients referred for TAVI , measurements of the aortic annulus using TTE , TEE , and MSCT were close but not identical , and the method used has important potential clinical implication s on TAVI strategy . In the absence of a gold st and ard , a strategy based on TEE measurements provided good clinical results AIMS TAVI is a minimally invasive alternative to surgical aortic valve replacement or medical therapy in patients with a high or prohibitive operative risk . The clinical significance of baseline anemia and prognostic implication s in this patient cohort are unknown . We sought to evaluate the prevalence and prognostic implication s of baseline anaemia in patients undergoing transcatheter aortic valve implantation ( TAVI ) at our institution . METHODS AND RESULTS One hundred and eighteen consecutive patients who underwent TAVI with the Medtronic Corevalve System ( Medtronic Corp. , Minneapolis , MN , USA ) were included in the analysis . Clinical and biochemical data were prospect ively collected before , during and after the procedure . Clinical follow-up was set at one month , one year and yearly thereafter . Anaemia was defined as a haemoglobin level < 13 g/dL in men and < 12 g/dL in women . Mortality was confirmed by consultation of the civil registry . The prevalence of baseline anaemia was 49 % . Anaemic patients undergoing TAVI  required more RBC transfusions ( 3.3 ± 3.1 versus 1.5 ± 2.3 ; p<0.001 ) and more frequently experienced a prolonged index hospitalisation exceeding two weeks . For patients with at least 1-year follow up ( N=74 ) , mortality at 30 days was no different ; however 1-year mortality was significantly higher in the anaemic cohort ( 44 versus 15 % , p=0.006 ) . In a multivariable analysis , baseline anaemia emerged as an independent predictor of 1- year mortality ( HR 2.10 [ 1.06 - 4.18 ] ) . CONCLUSIONS In our series , baseline anaemia is common in patients undergoing TAVI  , forecasts a need for more red blood cell transfusions and is associated with increased 1-year mortality OBJECTIVES Surgical aortic valve replacement in patients with previous coronary artery bypass grafting ( CABG ) carries a high mortality . Transcatheter aortic valve implantation ( TAVI ) has been shown to be successful in high risk subgroups of patients . Our goal is therefore to evaluate the impact of a history of CABG on the outcome of patients who undergo TAVI .  METHODS From October 2006 to June 2010 , among the 201 patients selected to undergo TAVI , 54 ( 27 % ) had a history of CABG .  Outcomes were prospect ively collected . RESULTS The 30-day outcome was not different between patients with previous CABG vs. those without , in particular as regards mortality ( respectively , 5.6 % vs. 10.9 % ; P = 0.25 ) . Mid-term survival ( mean FU : 7 ± 9 months ) was not different at 2 years between patients with previous CABG vs. patients without ( 65.7 ± 6.2 % vs. 80.0 ± 7.7 % respectively ; P = 0.12 ) . In multivariate analysis , CABG was not associated with an excess mid-term mortality  after TAVI . CONCLUSIONS Previous CABG does not adversely affect outcome in patients  undergoing TAVI . If confirmed by larger prospect i ve series and ideally by a r and omized trial comparing CABG vs. redo surgery , this observation might lead the heart team to consider TAVI as an attractive option in the population of high risk patients with aortic stenosis and previous CABG 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 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 In a fraction of patients aged ≥90 years , less-invasive transcatheter aortic valve implantation ( TAVI ) has been considered a therapeutic option for aortic stenosis under careful clinical screening . However , the safety and effectiveness using TAVI in such a population has not been fully eluci date d. The aim of the present study was to investigate the feasibility of TAVI in nonagenarians . We prospect ively enrolled 136 consecutive patients with severe aortic stenosis who were referred for TAVI .  The procedural , early , and midterm clinical outcomes were compared between patients aged < 90 years ( n = 110 , average age 82.3 ± 8.3 years ) and ≥90 years ( n = 26 ; average age 91.6 ± 1.9 years ) . A comparison of the baseline characteristics revealed that among patients aged ≥90 years , the prevalence of women ( 50 % vs 81 % , p < 0.001 ) and the mean aortic valve gradient ( 45.5 ± 15.4 vs 56.3 ± 23.4 mm Hg , p = 0.005 ) were greater than those in patients aged < 90 years . Major vascular complications occurred more frequently in patients ≥90 years ( 5 % vs 19 % , p = 0.022 ) , although the rate of procedural success and 30-day and 6-month mortality were not different between the 2 age groups ( 96 % vs 100 % , p = 0.58 ; 6 % vs 15 % , p = 0.22 ; and 14 % vs 27 % , p = 0.14 , respectively ) . The mortality rates were greater among patients aged ≥90 years . At 6 months , both groups of survivors were similar in symptom status , with a New York Heart Association classification less than class II ( 89 % vs 84 % , p = 0.68 ) . The cumulative survival ( median 13.4 ± 8.0 months of follow-up ) was not significantly different between the 2 age groups ( p = 0.22 , log-rank test ) . In conclusion , even very elderly nonagenarians can experience acceptable clinical results and benefits after TAVI BACKGROUND Many patients with severe aortic stenosis and coexisting conditions are not c and i date s for surgical replacement of the aortic valve . Recently , transcatheter aortic-valve implantation ( TAVI ) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis . METHODS We r and omly assigned patients with severe aortic stenosis , whom surgeons considered not to be suitable c and i date s for surgery , to st and ard therapy ( including balloon aortic valvuloplasty ) or transfemoral transcatheter implantation of a balloon-exp and able bovine pericardial valve .  The primary end point was the rate of death from any cause . RESULTS A total of 358 patients with aortic stenosis who were not considered to be suitable c and i date s for surgery underwent r and omization at 21 centers ( 17 in the United States ) . At 1 year , the rate of death from any cause ( Kaplan – Meier analysis ) was 30.7 % with TAVI , as compared with 50.7 % with st and ard therapy ( hazard ratio with TAVI , 0.55 ; 95 % confidence interval [ CI ] , 0.40 to 0.74 ; P<0.001 ) . The rate of the composite end point of death from any cause or repeat hospitalization was 42.5 % with TAVI as compared with 71.6 % with st and ard therapy ( hazard ratio , 0.46 ; 95 % CI , 0.35 to 0.59 ; P<0.001 ) . Among survivors at 1 year , the rate of cardiac symptoms ( New York Heart Association class III or IV ) was lower among patients who had undergone TAVI than among those who had received st and ard therapy ( 25.2 % vs. 58.0 % , P<0.001 ) . At 30 days , TAVI , as compared with st and ard therapy , was associated with a higher incidence of major strokes ( 5.0 % vs. 1.1 % , P=0.06 ) and major vascular complications ( 16.2 % vs. 1.1 % , P<0.001 ) . In the year after TAVI , there was no deterioration in the functioning of the bioprosthetic valve , as assessed by evidence of stenosis or regurgitation on an echocardiogram . CONCLUSIONS In patients with severe aortic stenosis who were not suitable c and i date s for surgery , TAVI , as compared with st and ard therapy , significantly reduced the rates of death from any cause , the composite end point of death from any cause or repeat hospitalization , and cardiac symptoms , despite the higher incidence of major strokes and major vascular events . ( Funded by Edwards Lifesciences ; Clinical Trials.gov number , NCT00530894 . ) 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 AIMS Treatment of elderly symptomatic patients with severe aortic stenosis and co-morbidities is challenging . Transcatheter aortic valve interventions [ balloon valvuloplasty and transcatheter aortic valve implantation ( TAVI ) ] are evolving as alternative treatment options to surgical valve replacement . We report the first results of the prospect i ve multi-centre German Transcatheter Aortic Valve Interventions -Registry . METHODS AND RESULTS Between January 2009 and December 2009 , a total of 697 patients ( 81.4 ± 6.3 years , 44.2 % males , and logistic EuroScore 20.5 ± 13.2 % ) underwent TAVI .  Pre-operative aortic valve area was 0.6 ± 0.2 cm² with a mean transvalvular gradient of 48.7 ± 17.2 mmHg . Transcatheter aortic valve implantation was performed percutaneously in the majority of patients [ 666 ( 95.6 % ) ] . Only 31 ( 4.4 % ) procedures were done surgically : 26 ( 3.7 % ) transapically and 5 ( 0.7 % ) transaortically . The Medtronic CoreValve ™ prosthesis was used in 84.4 % , whereas the Sapien Edwards ™ prosthesis was used in the remaining cases . Technical success was achieved in 98.4 % with a post-operative mean transaortic pressure gradient of 5.4 ± 6.2 mmHg . Any residual aortic regurgitation was observed in 72.4 % of patients , with a significant aortic insufficiency ( ≥ Grade III ) in only 16 patients ( 2.3 % ) . Complications included pericardial tamponade in 1.8 % and stroke in 2.8 % of patients . Permanent pacemaker implantation after TAVI became necessary in 39.3 % of patients . In-hospital death rate was 8.2 % , and the 30-day death rate 12.4 % . CONCLUSION In this real-world registry of high-risk patients with aortic stenosis  , TAVI had a high success rate and was associated with moderate in-hospital complications . However , careful patient selection and continued hospital selection seem crucial to maintain these results Objective To determine the cost-effectiveness of transcatheter aortic valve implantation ( TAVI ) compared with surgical aortic valve replacement ( SAVR ) in a high-risk aortic stenosis ( AS ) population . Design A cost-utility analysis employing the National Institute of Clinical Excellence ( NICE ) reference case design for technology appraisal s. Setting The perspective of the UK National Health Service . Patients Utility data from a UK high-risk AS population .  TAVI and SAVR effectiveness was taken from the PARTNER A r and omised controlled trial . Main outcome measures Costs modelled over a 10 year horizon using a Markov model . Incremental cost-effectiveness ratios and cost-effectiveness acceptability curve were calculated with reference to the NICE willingness to pay per quality adjusted life year ( QALY ) gain threshold . Deterministic and probabilistic sensitivity analyses performed . Results Despite greater procedural costs ( £ 16 500 vs £ 9,256 ) , TAVI was cost-effective compared with SAVR over the 10 year model horizon ( costs £ 52 593 vs £ 53 943 and QALYs 2.81 vs 2.75 ) , indicating that TAVI dominated SAVR . This appeared to be due to greater postsurgical costs , related to the length and cost of hospital stay . The results appeared robust to a number of deterministic sensitivity and probabilistic analyses . The cost-effectiveness acceptability curve indicated that at the NICE £ 20 000 willingness to pay threshold per QALY gained , TAVI had a 64.6 % likelihood of being cost-effective , compared with 35.4 % for SAVR . Conclusions TAVI is likely to be a cost-effective treatment for high-risk patients with AS compared with the reference st and ard of SAVR . However , uncertainty surrounding the long-term outcomes for TAVI  patients remains ; this could have a substantive impact on estimates of cost-effectiveness OBJECTIVES Transcatheter aortic valve implantation ( TAVI ) is an established intervention for aortic stenosis . While it is known that the requirement for permanent pacing is higher following CoreValve ( Medtronic , Inc. , Minneapolis , MN , USA ) TAVI than after surgical aortic valve replacement ( SAVR ) , it remains uncertain whether pacing is required in the medium-to-long term . We hypothesized that complete heart block following TAVI is more likely to resolve than that following SAVR . METHODS A retrospective analysis of prospect ively collated data on 528 patients undergoing TAVI or SAVR from May 2008 to December 2010 at a cardiac tertiary referral hospital .  Demographic data , timing and indication for pacing  post-procedure plus follow-up were recorded . Paced patients were compared and analysed by existing initial indication for pacing . RESULTS In total , 31 ( 5.9 % ) patients received a pacemaker , and there were limited differences between not paced and paced patient characteristics by procedure type . Of these , a greater proportion were implanted post-TAVI compared with SAVR ( 17 vs 3.2 % , P<0.001 ) . The mean time to pacemaker follow-up for TAVI and SAVR was 234 and 188 days , P=0.32 , respectively . Fewer patients compared with pacing indication remained in complete heart block at latest follow-up for TAVI ( 76.5 vs 33.3 % , P=0.02 ) and SAVR ( 92.9 vs 58.3 % , P=0.04 ) . Although , there was a trend towards a greater magnitude of TAVI patients regaining atrioventricular nodal conduction , this did not differ significantly from that seen in SAVR patients . CONCLUSIONS In keeping with previous reports , this single-centre experience demonstrates that patients undergoing TAVI  have higher rates of pacemaker implantation than those following SAVR . However , pacing indication in the short-to-medium term may not persist for all paced patients post-TAVI and -SAVR with the suggestion that a significant proportion recover atrioventricular conduction , which tended to be greatest in TAVI paced patients BACKGROUND A significant proportion of patients undergoing transcatheter aortic valve implantation ( TAVI )  have concomitant peripheral arterial disease ( PAD ) , which plays a crucial role in the preinterventional selection process of determining an optimal vascular access site . The aim of our study was to determine the impact of PAD on clinical outcome after TAVI in a real-world setting . METHODS A total of 1,315 patients ( mean logistic European System for Cardiac Operative Risk Evaluation 20.6 % ± 13.7 % ) underwent TAVI in 27 centers and were included in the prospect i ve German TAVI Registry . RESULTS Of the 1,315 patients with TAVI , 330 ( 25.1 % ) had PAD . These patients had a higher logistic European System for Cardiac Operative Risk Evaluation score ( 27.7 % ± 16.0 % vs 18.3 % ± 12.0 % , P < .0001 ) , mainly attributed to more frequent and severe comorbidities . Compared with patients without PAD , patients with PAD had a higher rate of vascular complications ( 28.5 % vs 20.7 % , P < .01 ) , dialysis-dependent renal failure ( 11.2 % vs 5.4 % , P < .001 ) , myocardial infa rct ion ( 1.2 % vs 0.3 % , P < .05 ) , and , subsequently , 30-day mortality ( 12.7 % vs 6.9 % , P < .001 ) . Choosing a surgical approach , for example , transapical access , did not reduce the periprocedural risk associated with PAD ; in-hospital mortality was 15.7 % for surgical and 10.5 % for percutaneous patients with TAVI having PAD ( P < .001 ) . In a multivariate regression analysis , PAD was an independent predictor of 30-day mortality ( hazard ratio 1.8 , 95 % CI 1.2 - 2.7 , P = .004 ) after TAVI . CONCLUSIONS In this real-world TAVI Registry , PAD was an independent predictor of mortality in  patients with percutaneous and surgical TAVI  , including vascular complications . Assessment of PAD should play a crucial role in the preinterventional selection process , regardless of the access strategy AIMS This analysis aim ed to evaluate the incidence and predictors of the need for  permanent pacemaker ( PPM ) implantation  following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System . METHODS AND RESULTS The prospect i ve , single-arm , multicentre REPRISE II study with extended cohort enrolled 250 symptomatic , high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation ( TAVI ) with a 23 mm or 27 mm LOTUS valve .  Echocardiography , computed tomography , and electrocardiography data were evaluated by independent core labs . Post TAVI , 32.0 % ( 72/225 ) of pacemaker-naïve patients underwent new PPM implantation at 30 days . Most ( 59/72 , 82 % ) patients were implanted for third-degree atrioventricular block , and > 10 % overstretch of the LVOT by area was observed in 59.7 % ( 43/72 ) of PPM patients . Significant independent predictors of PPM at 30 days included baseline RBBB ( odds ratio [ OR ] 12.7 , 95 % CI : 4.5 , 36.2 ; p<0.001 ) and LVOT overstretch > 10 % ( OR 3.4 , 95 % CI : 1.7 , 6.7 ; p<0.001 ) . There was a trend towards a lower 30-day PPM rate in patients with a shallower ( ≤5 mm ) implant depth ( 23.9 % ≤5 mm vs. 36.9 % > 5 mm depth from LCS ; p=0.06 ) . CONCLUSIONS Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve 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 Background Increased exercise capacity favourably influences clinical outcomes after  transcatheter aortic valve implantation .  In our SPORT : TAVI r and omised pilot trial , eight weeks of endurance and resistance training ( training group , TG ) shortly after transcatheter aortic valve implantation result ed in significantly improved exercise capacity , muscular strength and quality of life compared to usual care ( UC ) . However , the long-term clinical benefits of such an intervention are unknown . Design A r and omised controlled trial . Methods SPORT : TAVI participants underwent re assessment of trial endpoints 24 ± 6 months after baseline : maximal oxygen uptake ( VO2peak ) and anaerobic threshold ( VO2AT ) were assessed with cardiopulmonary exercise testing , muscular strength with one-repetition maximum testing , quality of life with the Kansas City cardiomyopathy and medical outcomes study 12-item short-form health survey question naires , and prosthetic aortic valve function with echocardiography . Results Of 27 original participants ( TG 13 ; UC 14 ; age 81 ± 6 years ) , more patients had died during follow-up in UC ( n = 5 ) than in TG ( n = 2 ; P = 0.165 ) ; three further patients ( TG 1 ; UC 2 ) were unavailable for other reasons . In the remaining patients ( TG 10 ; UC 7 ) , a significant between-group difference in favour of TG was observed for change in VO2AT from baseline ( 2.7 ml/min/kg ( 95 % confidence interval 0.8–4.6 ) ; P = 0.008 ) , but not for change in VO2peak ( 2.1 ml/min/kg ( –1.1–5.4 ) ; P = 0.178 ) . Changes in muscular strength and quality of life did not differ between groups over time . Overall , prosthetic valve function remained intact in both groups . Conclusions Eight weeks of exercise training shortly after transcatheter aortic valve implantation result ed in preserved long-term improvements in VO2AT , but not VO2peak , muscular strength or quality of life compared to usual care . The findings emphasise the importance of ongoing exercise interventions following transcatheter aortic valve implantation to maintain initial improvements long term . Clinical Trial Registration ( original trial ) : Clinical trials.gov NCT01935297
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 ) .