Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study. Incidence rate and predictors of permanent pacemaker implantation after transcatheter aortic valve implantation with self-expanding CoreValve prosthesis Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve Ongoing requirement for pacing post-transcatheter aortic valve implantation and surgical aortic valve replacement. Transcatheter aortic valve implantation in lower-risk patients: what is the perspective? Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: Analysis from the german transcatheter aortic valve interventions registry Electrocardiographic Predictors of Long‐Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation Ventricular arrhythmias in aortic valve stenosis before and after transcatheter aortic valve implantation. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. 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. 5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis. Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. Registry of transcatheter aortic-valve implantation in high-risk patients. Transcatheter versus Surgical Aortic Valve Replacement in High-risk Patients: A propensity-score matched analysis. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience. Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes. Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI 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. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. Permanent pacemaker implantation after transapical transcatheter aortic valve implantation. A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis. Incidence, predictive factors, and prognostic value of new-onset atrial fibrillation following transcatheter aortic valve implantation. Aortic valve stenosis after previous coronary bypass: Transcatheter valve implantation or aortic valve replacement? Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Drivers of healthcare costs associated with the episode of care for surgical aortic valve replacement versus transcatheter aortic valve implantation Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry. 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. Comparison of effectiveness and safety of transcatheter aortic valve implantation in patients aged ≥90 years versus <90 years. Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score Impact of gender on three-month outcome and left ventricular remodeling after transfemoral transcatheter aortic valve implantation. Preserved prognostic value of preinterventional troponin T levels despite successful TAVI in patients with severe aortic stenosis One year follow-up of the multi-centre European PARTNER transcatheter heart valve study SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation.
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 OBJECTIVES The aim of the CoreValve prospect i ve , international , post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation ( PPI )  after transcatheter aortic valve replacement with the Medtronic CoreValve System ( Minneapolis , Minnesota ) using optimized implantation techniques and application of international guidelines on cardiac pacing . BACKGROUND Conduction disturbances are a frequent complication of transcatheter aortic valve replacement . The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI . METHODS The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth ( ≤6 mm below the aortic annulus ) . The timing and resolution of all new-onset conduction disturbances were analyzed . RESULTS A total of 194 patients were treated . The overall rate of PPI for Class I/II indications was 18.2 % . An optimal depth was reached in 43.2 % of patients , with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm , compared with those with deeper implants ( 13.3 % vs. 21.1 % ; p = 0.14 ) . In a paired analysis , new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4 % and 39.0 % of patients , respectively , and resolved spontaneously within 30 days in 43.2 % and 73.9 % , respectively . In patients with new PPI , the rate of intrinsic sinus rhythm increased from 25.9 % at 7 days to 59.3 % at 30 days ( p = 0.004 ) . CONCLUSIONS Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement , compared with results reported in previous studies . ( CoreValve Advance-II Study : Prospect i ve International Post-Market Study [ ADVANCE II ] ; NCT01624870 ) 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 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 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 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 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 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 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 AIMS This study sought to investigate outcomes of transcatheter aortic valve implantation ( TAVI ) with the SAPIEN 3 transcatheter heart valve ( THV ) in patients at intermediate risk for surgery . The 30-day results of the transfemoral cohort are reported . METHODS AND RESULTS The SAPIEN 3 European approval trial intermediate-risk cohort included a total of 101 patients with severe , symptomatic aortic stenosis , at intermediate risk for surgery suitable for TAVI via the transfemoral route ( TF ) . Outcomes were adjudicated by a clinical events committee . Echocardiography , computed tomography and electrocardiography exams were analysed in core laboratories . The mean STS-PROM score and logistic EuroSCORE of the study population were 5.2±1.7 and 13.2±3.8 , respectively . A completely percutaneous procedure was performed in 90.1 % of patients and conscious sedation and /or local anaesthesia was utilised in 54.5 % . Technical success was achieved in 98.0 % of patients . At 30 days , mortality was 1.0 % , with stroke in 3.0 % and a new permanent pacemaker in 4.0 % ( 4.3 % of patients without pre-procedural permanent pacemaker ) . No patients had severe aortic regurgitation after the procedure , only one patient had moderate aortic regurgitation , and 70.8 % of patients had no or trace aortic regurgitation . CONCLUSIONS TF-TAVI using the SAPIEN 3 THV in patients at intermediate risk for surgery is associated with a very low risk of death and complications , including new pacemakers and paravalvular leaks . Although compelling , these initial results are being confirmed in larger global studies before exp and ing the indications for TAVI in severe aortic stenosis 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 OBJECTIVES The purpose of this analysis was to assess 5-year outcomes of  transcatheter aortic valve implantation ( TAVI )  using the current technology of the self-exp and ing CoreValve prosthesis ( Medtronic Inc. , Minneapolis , Minnesota ) . BACKGROUND There is a paucity of evidence on long-term durability of currently available transcatheter heart valves . METHODS Starting in June 2007 , all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospect ively included in the Clinical Service Project . For the purpose s of this study , we included only consecutive patients with 5-year follow-up data available ( n = 353 ) treated from June 2007 to August 2009 . All outcomes were reported according to VARC ( Valve Academic Research Consortium)-1 criteria . RESULTS All-cause mortality rates at 1 , 2 , 3 , 4 , and 5 years were 21 % , 29 % , 38 % , 48 % , and 55.0 % , respectively . Cardiovascular mortality rates at 1 , 2 , 3 , 4 , and 5 years were 10 % , 14 % , 19 % , 23 % , and 28.0 % , respectively . The overall neurological event rate at 5 years was 7.5 % , of which more than two-thirds occurred early after the procedure . During follow-up , there were 241 rehospitalizations for cardiovascular reasons in 164 ( 46 % ) patients . Among all rehospitalizations , acute heart failure was the most frequently reported ( 42.7 % ) , followed by requirement of permanent pacemaker implantation ( 17.4 % ) . On echocardiography , mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg ( pre-TAVI ) to 12.8 ± 10.9 mm Hg ( 5-year post-TAVI ) ( p < 0.001 ) . Late prosthesis failure occurred in 5 cases ( 1.4 % ) ; among these , redo TAVI was successfully carried out in 2 patients ( 0.6 % ) presenting with symptomatic prosthesis restenosis . The remaining 3 cases of prosthesis failure did not undergo further invasive interventions . Ten patients ( 2.8 % ) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg . No other cases of structural or nonstructural valvular deterioration were observed . Valve thrombosis or late valve embolization were not reported . CONCLUSIONS TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up , with a low rate ( 1.4 % ) of significant prosthetic valve degeneration . The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients AIMS Data on procedural and clinical outcomes after  transcatheter aortic valve implantation ( TAVI )  with the new-generation self-exp and ing Medtronic Evolut R prosthesis in comparison with its predecessor , the Medtronic CoreValve , are scarce . The aim of this study was to assess the safety and efficacy of the Evolut R device compared with the former-generation CoreValve . METHODS AND RESULTS In a nationwide , prospect i ve , multicentre cohort study , outcomes of consecutive transfemoral TAVI patients treated with the new-generation Medtronic Evolut R ( September 2014 - February 2016 ) and the Medtronic CoreValve ( February 2011 - February 2016 ) were investigated . Events were reported according to VARC-2 and adjudicated by a clinical events committee . During the study period , 317 and 678 consecutive patients underwent TAVI with the Evolut R and the CoreValve bioprosthesis , respectively . Baseline clinical characteristics between the groups were comparable , although Evolut R patients were lower risk according to the STS score ( 4.8±3.4 % vs. 6.9±5.0 % , p<0.001 ) and logistic EuroSCORE ( 17.3±13 % vs. 20.1±13 % , p=0.009 ) . Implantation of the Evolut R was associated with a lower use of predilatation ( 48.1 % vs. 72.4 % , p<0.001 ) , a shorter procedure time ( 67.9±36 min vs. 76.7±42 min , p=0.002 ) , and less contrast dye use during the procedure ( 155.2±98 ml vs. 208.0±117 ml , p<0.001 ) . Post-procedural mean gradient was comparable ( 7.4±4.7 mmHg vs. 7.5±5.0 mmHg ) , as were the 30-day rates of moderate to severe aortic regurgitation ( 8.5 % vs. 10.5 % ) , major vascular ( 9.8 % vs. 10.3 % ) and life-threatening bleeding complications ( 5.4 % vs. 5.3 % ) , disabling stroke ( 1.9 % vs. 1.6 % ) , all-cause mortality ( 3.2 % vs. 3.4 % ) as well as permanent pacemaker implantation ( 22.1 % vs. 23.4 % ) . CONCLUSIONS Thirty-day clinical outcomes were favourable and comparable between the Evolut R and the CoreValve bioprosthesis 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 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 AIMS Transcatheter aortic valve implantation ( TAVI ) requires large bore catheters . Access site complications , therefore , can be a concern . The aim of this study is to present the 30-day incidence of major and minor vascular complications in patients treated with the third generation 18 Fr Medtronic CoreValve System .  METHODS AND RESULTS We prospect ively evaluated the vascular complications occurring in all patients treated with the 18 Fr Medtronic CoreValve System between October 2006 and October 2009 in the Thoraxcenter using various proposed definitions . Ninety-nine consecutive patients were treated with TAVI using the 18 Fr Medtronic CoreValve System .  Vascular events were encountered in 13 patients ( 13 % ) , seven of these cases ( 54 % ) were related to incomplete arteriotomy closure with the Prostar device which is the default access closure technique in our centre . Depending on how major vascular complications were defined , the incidence varied from 4 to 13 % . Blood transfusions in combination with surgical or percutaneous intervention were required in eight cases . CONCLUSIONS Transcatheter aortic valve implantation with the 18 Fr Medtronic CoreValve System(R ) has a 4 to 13 % vascular complications ' rate . More than half of the vascular events were due to incomplete Prostar arteriotomy closure , despite its use by experienced operators . Current percutaneous closure devices for these large arteriotomies seems suboptimal . Uniformity in how to define TAVI related vascular complications is needed 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 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 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 OBJECTIVES The aim of this study was prospect i ve investigation of silent and clinical ly apparent cerebral embolic events and neurological impairment after  transfemoral aortic valve implantation ( TAVI ) .  BACKGROUND TAVI is a novel therapeutic approach for multimorbid patients with severe aortic stenosis . We investigated peri-interventional cerebral embolism with diffusion-weighted magnetic resonance imaging ( DW-MRI ) and its relationship to clinical and serologic parameters of brain injury . METHODS Cerebral DW-MRI was performed before , directly , and 3 months after  TAVI  with the current third-generation self-exp and ing CoreValve ( Medtronic , Minneapolis , Minnesota ) prosthesis . At the timepoints of the serial MRI studies , focal neurological impairment was assessed according to the National Institutes of Health Stroke Scale ( NIHSS ) , and serum concentration of neuron-specific enolase ( NSE ) , a marker of the volume of brain tissue involved in an ischemic event , were determined . RESULTS Thirty patients were enrolled ; 22 completed the imaging protocol . Three patients ( 10 % ) had new neurological findings after TAVI , of whom only 1 ( 3.6 % ) had a permanent neurological impairment . Of the 22 TAVI patients with complete imaging data , 16 ( 72.7 % ) had 75 new cerebral lesions after TAVI presumed to be embolic . The NIHSS and NSE were not correlated with DW-MRI lesions . CONCLUSIONS The incidence of clinical ly silent peri-interventional cerebral embolic lesions after TAVI is high . However , in this cohort of 30 patients , the incidence of persistent neurological impairment was low . ( Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement ; NCT00883285 ) The aim of the study was to determine the incidence of permanent pacemaker implantation ( PPMI ) in a cohort of 358 patients undergoing transapical aortic valve implantation ( TAVI ) using a balloon-exp and able prosthesis between April 2008 and March 2011 . After excluding patients who had had a previous PPMI ( n=36 ; 10 % ) , the study group consisted of 322 patients . These were divided into two groups : patients who required PPMI ( PPM group ) and patients who did not require it ( non-PPM group ) . Preoperative , perioperative and one-year follow-up data were collected prospect ively . Twenty ( 6.2 % ) patients required PPMI . Previous implantation of an aortic prosthesis ( P = non-significant ) , previous coronary artery bypass grafting ( P=0.05 ) and coronary artery disease ( P<0.005 ) were more common in the non-PPM group . On logistic regression , only patient age seemed to be correlated to PPMI ( P=0.05 , odds ratio 1.08 ; CI 0.9 - 1.1 ) . There was no difference in survival rate between the groups after 30 days ( PPM group 95 % , non-PPM group 93.6 % ) . Similarly , the survival rate did not differ after one year ( PPM group 84 % , non-PPM group 80.9 % ; P=0.3 ) . The PPMI rate after transapical TAVI using a balloon-exp and able prosthesis is thus low , and has no impact on early and follow-up mortality AIMS Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System ( DFM-TAVS ) , when used in routine clinical practice . METHODS AND RESULTS This is a prospect i ve , open-label , multicentre , post-market registry of patients treated with DFM-TAVS according to approved commercial indications . Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee . The primary endpoint was freedom from all-cause mortality at 30 days post procedure . Secondary endpoints included procedural , early safety and efficacy endpoints at 30 days . Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation ( TAVI ) with the DFM-TAVS were enrolled in 21 European centres . The primary endpoint , freedom from all-cause mortality at 30 days , was met in 98 % ( 245/250 ) of patients . Device success was 83.8 % . Moderate or severe aortic regurgitation was reported in 3 % of patients , and none/trace regurgitation in 73 % of patients . Post-procedural permanent pacemaker implantation was performed in 30 patients ( 12.0 % ) . CONCLUSIONS The DFM-TAVS was associated with good short-term outcomes in this real-world registry . The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve ( THV ) 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 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 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 Transcatheter aortic valve implantation ( TAVI ) is generally more expensive than surgical aortic valve replacement ( SAVR ) due to the high cost of the device . Our objective was to underst and the patient and procedural drivers of cumulative healthcare costs during the index hospitalisation for these procedures . Design All patients undergoing TAVI , isolated SAVR or combined SAVR+coronary artery bypass grafting ( CABG ) at 7 hospitals in Ontario , Canada were identified during the fiscal year 2012–2013 . Data were obtained from a prospect i ve registry . Cumulative healthcare costs during the episode of care were determined using microcosting . To identify drivers of healthcare costs , multivariable hierarchical generalised linear models with a logarithmic link and γ distribution were developed for TAVI , SAVR and SAVR+CABG separately . Results Our cohort consisted of 1310 patients with aortic stenosis , of whom 585 underwent isolated SAVR , 518 had SAVR+CABG and 207 underwent TAVI .  The median costs for the index hospitalisation for isolated SAVR were $ 21 811 ( IQR $ 18 148–$30 498 ) , while those for SAVR+CABG were $ 27 256 ( IQR $ 21 741–$39 000 ) , compared with $ 42 742 ( IQR $ 37 295–$56 196 ) for TAVI . For SAVR , the major patient-level drivers of costs were age > 75 years , renal dysfunction and active endocarditis . For TAVI , chronic lung disease was a major patient-level driver . Procedural drivers of cost  for TAVI included a non-transfemoral approach . A prolonged intensive care unit stay was associated with increased costs for all procedures . Conclusions We found wide variation in healthcare costs  for SAVR compared with TAVI , with different patient-level drivers as well as potentially modifiable procedural factors . These highlight areas of further study to optimise healthcare delivery 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 . ) OBJECTIVES The study sought to examine the safety and performance of transcatheter aortic valve replacement ( TAVR ) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR . BACKGROUND Although women comprise 50 % of patients with symptomatic severe aortic stenosis undergoing TAVR  , the optimal treatment strategy remains undetermined . METHODS The WIN-TAVI ( Women 's INternational Transcatheter Aortic Valve Implantation ) registry is a multinational , prospect i ve , observational registry of women undergoing TAVR for aortic stenosis , conducted without any external funding . The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days ( composite of mortality , stroke , major vascular complication , life-threatening bleeding , stage 2 or 3 acute kidney injury , coronary artery obstruction , or repeat procedure for valve-related dysfunction ) . RESULTS Between January 2013 and December 2015 , 1,019 women were enrolled across 19 European and North American centers . The mean patient age was 82.5 ± 6.3 years , mean EuroSCORE I was 17.8 ± 11.7 % and mean Society of Thoracic Surgeons score was 8.3 ± 7.4 % .  TAVR was performed via transfemoral access in 90.6 % and new-generation devices were used in 42.1 % . In more than two-thirds of cases , an Edwards SAPIEN 23 mm ( Edwards Lifesciences , Irvine , California ) or Medtronic CoreValve ≤26 mm ( Medtronic Inc. , Minneapolis , Minnesota ) device was implanted . The 30-day VARC-2 composite endpoint occurred in 14.0 % with 3.4 % all-cause mortality , 1.3 % stroke , 7.7 % major vascular complications , and 4.4 % VARC life-threatening bleeding . The independent predictors of the primary endpoint were age ( odds ratio [ OR ] : 1.04 ; 95 % confidence interval [ CI ] : 1.00 to 1.08 ) , prior stroke ( OR : 2.02 ; 95 % CI : 1.07 to 3.80 ) , left ventricular ejection fraction < 30 % ( OR : 2.62 ; 95 % CI : 1.07 to 6.40 ) , new device generation ( OR : 0.59 ; 95 % CI : 0.38 to 0.91 ) , and history of pregnancy ( OR : 0.57 ; 95 % CI : 0.37 to 0.85 ) . CONCLUSIONS Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters , were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0 % with a low incidence of early mortality and stroke . R and omized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy 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 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 Objective Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation ( TAVI ) . We identified the factors associated with early mortality after TAVI and aim ed to develop and vali date a simple risk score . Methods A population of 3833 consecutive patients was r and omly split into two cohorts comprising 2552 and 1281 patients , used respectively to develop and vali date a scoring system predicting 30-day or in-hospital mortality . Results TAVI was performed using the Edwards Sapien prosthesis in 2551 ( 66.8 % ) patients and the Medtronic Corevalve in 1270 ( 33.2 % ) . Approach was transfemoral in 2801 ( 73.4 % ) patients , transapical in 678 ( 17.8 % ) , subclavian in 219 ( 5.7 % ) and other in 117 ( 3.1 % ) . Early mortality was 10.0 % ( 382 patients ) . A multivariate logistic model identified the following predictive factors of early mortality : age ≥90 years , body mass index < 30 Kg/m2 , New York Heart Association class IV , pulmonary hypertension , critical haemodynamic state , ≥2 pulmonary oedemas during the last year , respiratory insufficiency , dialysis and transapical or other ( transaortic and transcarotid ) approaches . A 21-point predictive score was derived . C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort . There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts . Conclusions Early mortality  after TAVI is mainly related to age , the severity of symptoms , comorbidities and transapical approach . A simple score can be used to predict early mortality  after TAVI . The moderate discrimination is however a limitation for the accurate identification of high-risk patients Transarterial aortic valve implantation ( TAVI ) is a promising method for the treatment of high-risk patients with aortic stenosis . Because gender differences are known in aortic stenosis , the aim of this study was to compare procedural and short-term outcomes , left ventricular remodeling , and inflammatory status after TAVI in men and women . One hundred consecutive patients ( 42 men , 58 women ) who underwent transfemoral TAVI ( CoreValve in 83 % , SAPIEN in 17 % ) were prospect ively analyzed .  Aortic stenosis severity was higher in women ( mean valve area 0.7 ± 0.3 vs 0.8 ± 0.2 cm(2 ) ) . Women had better ejection fractions , smaller end-diastolic and end-systolic diameters , and more concentric hypertrophy at baseline . There were no differences in device success rate ( 99 % ) , 30-day total mortality ( 2.4 % in men , 3.4 % in women ) , stroke ( 2.4 % in men , 1.7 % in women ) , or pacemaker rate ( 26.2 % in men , 15.5 % in women ) . Periprocedural complications and 3-month outcome were not different between the genders . After TAVI  , regression of hypertrophy occurred in men and women , but improvement of the ejection fraction was significant only in women . N-terminal pro-B-type natriuretic peptide decreased to similar levels in the 2 genders . C-reactive protein and interleukin-6 , elevated at baseline more in men than in women , decreased after TAVI and normalized at 3 months only in women . In conclusion , women clinical ly benefit from TAVI to a degree similar to that of men . However , there are gender differences involving the recovery response of the left ventricle after TAVI 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 Background Transcatheter aortic valve implantation ( TAVI ) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis . Aims PARTNER EU is the first study to evaluate prospect ively the procedural and mid-term outcomes of transfemoral ( TF ) or transapical ( TA ) implantation of the Edwards SAPIEN ® valve involving a multi-disciplinary approach . Methods and results Primary safety endpoints were 30 days and 6 months mortality . Primary efficacy endpoints were haemodynamic and functional improvement at 12 months . One hundred and thirty patients ( 61 TF , 69 TA ) , aged 82.1 ± 5.5 years were included . TA patients had higher logistic EuroSCORE ( 33.8 vs. 25.7 % , P = 0.0005 ) and more peripheral disease ( 49.3 vs. 16.4 % , P < 0.0001 ) . Procedures were aborted in four TA ( 5.8 % ) and six TF cases ( 9.8 % ) . Valve implantation was successful in the remaining patients in 95.4 and 96.4 % , respectively . Thirty days and 6 months survival were 81.2 and 58.0 % ( TA ) and 91.8 and 90.2 % ( TF ) . In both groups , mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI . In total , 78.1 and 84.8 % of patients experienced significant improvement in New York Heart Association ( NYHA ) class , whereas 73.9 and 72.7 % had improved Kansas City Cardiomyopathy Question naire ( KCCQ ) scores in TA and TF cohorts , respectively . Conclusion This first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA  delivery . Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort . Optimal patient screening , approach selection , and device refinement may improve outcomes BACKGROUND Common clinical practice recommends dual antiplatelet therapy ( DAPT ) for  transcatheter aortic valve implantation ( TAVI ) . The aim of the study was to evaluate , in a double blind r and omized study , the safety of TAVI , with adjunctive pharmacotherapy consisting of single antiplatelet therapy . METHODS AND RESULTS From April 2010 to April 2011 , 120 consecutive patients , undergoing TAVI , have been enrolled in the study . Patients were r and omly assigned to DAPT group ( aspirin and clopidogrel 75 mg/qd or ticlopidine 500 mg/bid ) or ASA group ( aspirin only ) . TAVI device was the Sapien XT-Novaflex Delivery System ( Edwards Lifesciences , Inc. ) . All patients were followed up to 6 months . Device success was achieved in 100 % of patients . No difference in the VARC combined 30 day safety endpoint , all cause and cardiovascular mortality was observed . At 30 days vascular complications were reduced in the ASA group ( p<0.05 ) . No differences in the clinical status were detected between the groups up to 6 months . CONCLUSIONS This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality . These findings , if confirmed in a larger multicenter r and omized trial , will no longer support the use of DAPT for TAVI
Specific recommendations for implantation of each prosthesis , taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors , may be needed to reduce the risk of PPI
Aims The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation ( PPI ) after transcatheter aortic valve implantation ( TAVI ) with new-generation prostheses remains debated .
This systematic review analyses the incidence of PPI after TAVI  with new-generation devices and evaluates the electrical , anatomical , and procedural factors associated with PPI .
In addition , the incidence of PPI after  TAVI with early generation prostheses was review ed for comparison .