Incidence rate and predictors of permanent pacemaker implantation after transcatheter aortic valve implantation with self-expanding CoreValve prosthesis 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. Electrocardiographic Predictors of Long‐Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System. Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: Analysis from the german transcatheter aortic valve interventions registry Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve Permanent pacemaker implantation after transapical transcatheter aortic valve implantation. 5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis. 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. Ongoing requirement for pacing post-transcatheter aortic valve implantation and surgical aortic valve replacement. Ventricular arrhythmias in aortic valve stenosis before and after transcatheter aortic valve implantation. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. Pre-Existing Right Bundle Branch Block Increases Risk for Death After Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve. 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. Transcatheter aortic valve implantation in lower-risk patients: what is the perspective? Stroke Complicating Transcatheter Aortic Valve Implantation: Incidence, Risk Factors and Outcome
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 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 requiring permanent pacemaker ( PPM ) implantation are a known complication of transcatheter aortic valve implantation ( TAVI ) . Indications for permanent pacing in this setting are still controversial . The study aim was to characterize the natural history of conduction disorders related to TAVI , and to identify predictors for long‐term pacing dependency . Methods Consecutive patients who underwent TAVI  were included in this prospect i ve observational study . The conduction system was investigated by review ing 12‐lead ECGs during hospitalization and up to 1‐year follow‐up and by analyzing pacemaker interrogation data . Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency . Results Of 110 patients included in the analysis , 38 ( 34.5 % ) underwent PPM implantation . Of those , 26 ( 68.4 % ) had a long‐term pacing dependency ( required PPM ) , while 12 ( 31.6 % ) did not ( not‐required PPM ) . Logistic regression revealed that baseline RBBB ( P = 0.01 , OR = 18.0 ) , baseline PR interval ( P = 0.019 , OR = 1.14 ) , post‐TAVI PR interval and the change in PR interval from baseline ( P < 0.001 for both , OR = 1.17 for each 10 milliseconds increment ) were independent predictors for long‐term pacing dependency . A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency . Conclusions Increased pre‐ and postprocedural PR intervals and pre‐existing RBBB are reliable predictors for long‐term PPM dependency , while left bundle branch block or QRS width are misleading factors . Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval BACKGROUND / 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 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 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 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 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 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 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 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 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 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 ) OBJECTIVES The aim of this study was to determine the impact of pre-existing right bundle branch block ( RBBB ) on clinical outcomes after  transcatheter aortic valve replacement ( TAVR ) .  BACKGROUND The impact of pre-existing RBBB on clinical outcomes after TAVR is unknown . METHODS Between October 2013 and August 2015 , 749 patients undergoing TAVR using the Edwards SAPIEN XT prosthesis were prospect ively enrolled in the OCEAN-TAVI ( Optimized Transcatheter Valvular Intervention ) registry from 8 Japanese centers .  Electrocardiograms  were obtained at baseline . After the procedure , follow-up outpatient visits or telephone interviews were conducted at 30 days , 6 months , and yearly . RESULTS A total of 102 patients ( 13.6 % ) had pre-existing RBBB . The incidence of new pacemaker implantation was significantly higher in the RBBB group ( 17.6 % vs. 2.9 % ; p < 0.01 ) . The Kaplan-Meier analysis revealed that cardiovascular survival probability was significantly lower in the RBBB group than the no-RBBB group ( log-rank p < 0.01 ) . Patients with RBBB and without pacemakers were at higher risk for cardiovascular mortality in the early phase after discharge , and patients with RBBB and pacemakers had higher cardiovascular mortality at mid-term follow-up ( log-rank p = 0.01 ) . A multivariate Cox regression model indicated that pre-existing RBBB ( hazard ratio : 2.59 ; 95 % confidence interval : 1.15 to 5.85 ; p < 0.01 ) was an independent predictor of cardiovascular mortality . CONCLUSIONS Patients with RBBB demonstrated an increased risk for cardiovascular mortality after TAVR , and patients with RBBB and without pacemakers were at higher risk for cardiac death early after discharge . Patients with prior RBBB should be carefully monitored after undergoing TAVR 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 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 Background Transcatheter aortic valve implantation is a novel therapeutic option for patients at high risk for surgical heart valve replacement that carries a risk for periprocedural stroke . Patients and methods Consecutive patients undergoing transcatheter aortic valve implantation with the self-exp and able Medtronic-Corevalve Revalving system were included in a single-centre prospect i ve data base . Strokes complicating transcatheter aortic valve implantation in the first five-days following the procedure were documented , and the differences between patients with and without stroke were studied . Results Seventy-two patients ( 32 men , mean age 80·5 ± 6·2 ) underwent transcatheter aortic valve implantation from September 2008 to April 2011 . Of these , eight ( 11 % ) had focal neurological deficits in the periprocedural period ( three transient ischaemic attacks , five strokes of which three were minor , one moderate , and one major ) . Patients with stroke/ transient ischaemic attacks did not differ from those without cerebral ischaemia in baseline criteria or procedural variables . Six of the events were believed to be embolic result ing from dislodgement of calcific material from the aortic valve , and one transient ischaemic attack was secondary to hypoperfusion during severe bradycardia . One patient with basilar occlusion died , but the remaining six patients survived and all had a modified Rankin score ≤2 at 90 days . None of the patients had a recurrent stroke during follow-up . Discussion Periprocedural cerebral ischaemia following transcatheter aortic valve implantation is not uncommon , but most patients have good outcomes . There was no particular pre-transcatheter aortic valve implantation or procedural risk factor profile that increased the risk for periprocedural stroke . Further studies are warranted to examine whether patients that are at higher risk for developing stroke after transcatheter aortic valve implantation can be identified
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 .