title: Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. 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. Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study. Safety and efficacy of a repositionable and fully retrievable aortic valve used in routine clinical practice: the RESPOND Study Transcatheter aortic valve implantation using the ACURATE TA and ACURATE neo valves: a four-year single-centre experience. Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries Contemporary transcatheter aortic valve replacement with third‐generation balloon‐expandable versus self‐expanding devices Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study. A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis. 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. Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Valve: United Kingdom Experience. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study Transcatheter aortic-valve replacement with a self-expanding prosthesis. Registry of transcatheter aortic-valve implantation in high-risk patients. Electrocardiographic Predictors of Long‐Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. Incidence rate and predictors of permanent pacemaker implantation after transcatheter aortic valve implantation with self-expanding CoreValve prosthesis Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family. Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. Ongoing requirement for pacing post-transcatheter aortic valve implantation and surgical aortic valve replacement. Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis. Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: results of the Belgian national registry. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. Surgical or Transcatheter Aortic‐Valve Replacement in Intermediate‐Risk Patients Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: Analysis from the german transcatheter aortic valve interventions registry Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters' Registry. Permanent pacemaker implantation after transapical transcatheter aortic valve implantation.
abstract: IMPORTANCE Transcatheter aortic valve replacement ( TAVR ) is an effective treatment option for high-risk patients with severe aortic stenosis . Different from surgery , transcatheter deployment of valves requires either a balloon-exp and able or self-exp and able system . A r and omized comparison of these 2 systems has not been performed . OBJECTIVE To determine whether the balloon-exp and able device is associated with a better success rate than the self-exp and able device . DESIGN , SETTING , AND PATIENTS The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure . One hundred twenty-one patients were r and omly assigned to receive a balloon-exp and able valve ( Edwards Sapien XT ) and 120 were assigned to receive a self-exp and able valve ( Medtronic CoreValve ) . Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany . INTERVENTIONS Transfemoral TAVR with a balloon-exp and able or self-exp and able device . MAIN OUTCOMES AND MEASURES The primary end point was device success , which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system , correct position of the device , intended performance of the heart valve without moderate or severe regurgitation , and only 1 valve implanted in the proper anatomical location . Secondary end points included cardiovascular mortality , bleeding and vascular complications , postprocedural pacemaker placement , and a combined safety end point at 30 days , including all-cause mortality , major stroke , and other serious complications . RESULTS Device success occurred in 116 of 121 patients ( 95.9 % ) in the balloon-exp and able valve group and 93 of 120 patients ( 77.5 % ) in the self-exp and able valve group ( relative risk [ RR ] , 1.24 , 95 % CI , 1.12 - 1.37 , P < .001 ) . This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation ( 4.1 % vs 18.3 % ; RR , 0.23 ; 95 % CI , 0.09 - 0.58 ; P < .001 ) and the less frequent need for implanting more than 1 valve ( 0.8 % vs 5.8 % , P = .03 ) in the balloon-exp and able valve group . Cardiovascular mortality at 30 days was 4.1 % in the balloon-exp and able valve group and 4.3 % in the self-exp and able valve group ( RR , 0.97 ; 95 % CI , 0.29 - 3.25 ; P = .99 ) . Bleeding and vascular complications were not significantly different , and the combined safety end point occurred in 18.2 % of those in the balloon-exp and able valve group and 23.1 % of the self-exp and able valve group ( RR , 0.79 ; 95 % CI , 0.48 - 1.30 ; P = .42 ) . Placement of a new permanent pacemaker was less frequent in the balloon-exp and able valve group ( 17.3 % vs 37.6 % , P = .001 ) . CONCLUSIONS AND RELEVANCE Among patients with high-risk aortic stenosis undergoing TAVR , the use of a balloon-exp and able valve result ed in a greater rate of device success than use of a self-exp and able valve . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01645202 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 ) OBJECTIVES This study sought to evaluate this transcatheter aortic valve ( TAV ) bioprosthesis in patients who are poorly suitable for surgical aortic valve ( AV ) replacement . BACKGROUND A novel self-exp and able TAV bioprosthesis was design ed to provide a low-profile delivery system , conformable annular sealing , and the ability to resheath and reposition during deployment . METHODS The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States . Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria . An independent echocardiography laboratory was used to evaluate hemodynamic outcomes . RESULTS Patients were elderly ( 83.3 ± 7.2 years of age ) and had high surgical risk ( Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4 % ) . The majority of patients ( 89.5 % ) were treated by iliofemoral access . Resheathing or recapturing was performed in 22.6 % of patients ; more than 1 valve was required in 3 patients ( 1.3 % ) . The 30-day outcomes included all-cause mortality ( 2.5 % ) , disabling stroke ( 3.3 % ) , major vascular complications ( 7.5 % ) , life-threatening or disabling bleeding ( 7.1 % ) , and new permanent pacemaker ( 16.4 % ) . AV hemodynamics were markedly improved at 30 days : the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg ( p < 0.001 ) and AV area increased from 0.6 ± 0.2 cm2 to 1.9 ± 0.5 cm2 ( p < 0.001 ) . Moderate residual paravalvular leak was identified in 5.3 % of patients . CONCLUSIONS We conclude that this novel self-exp and ing TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery . ( Medtronic CoreValve Evolut R U.S. Clinical Study ; NCT02207569 ) Aims RESPOND is a prospect i ve , open-label , single-arm study evaluating the outcomes following transcatheter aortic valve implantation ( TAVI ) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis . Methods and results RESPOND enrolled 1014 patients at sites across Europe , New Zeal and , and Latin America ; 996 patients received a Lotus Valve ( mean age : 80.8 years ; 50.8 % female ; Society of Thoracic Surgeons score : 6.0 ± 6.9 ) . Repositioning was attempted in 29.2 % of patients , with 99 % success . The rate of all-cause mortality in the intent-to-treat population at 30 days ( primary endpoint ) was 2.6 % ( P < 0.001 vs. pre-specified performance goal ) . Thirty-day clinical follow-up was completed for 97.3 % of patients . Among patients who received a Lotus Valve , the 30-day overall and disabling stroke rates were 3.0 % and 2.2 % , respectively . The 30-day permanent pacemaker implantation rate was 30.0 % in all patients , and 34.6 % in pacemaker-naïve patients . Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory . Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge ( P < 0.001 ) . Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge ( P < 0.001 ) . At hospital discharge , paravalvular leak ( PVL ) was absent or trace in 92 % of patients ; no patients had severe PVL , 0.3 % of patients exhibited moderate PVL , and 7.7 % of patients had mild PVL . Clinical follow-up in RESPOND will extend to 5 years . Conclusion The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice . Trial registration Clinical Trials.gov # NCT 02031302 AIMS Long-term outcomes are available for first-generation transcatheter heart valves but data on second-generation devices are scarce . We aim ed to provide an oversight of all patients implanted with a second-generation valve in our centre . METHODS AND RESULTS From April 2012 to July 2016 , 219 patients were enrolled in this prospect i ve single-centre experience ; they received either the transapical ACURATE TA ( n=99 ) or the transfemoral ACURATE neo ( n=120 ) prosthesis . Data were collected during the hospital stay and telephone follow-ups were conducted at 30 days post procedure and annually thereafter . Patients were 80.9±4.4 years old with a mean logistic EuroSCORE I of 19.3±13.9 % . Transapical patients had significantly more comorbidities at baseline . Post intervention , mean gradient was reduced to 10.6±9.2 mmHg , and 1.9 % had moderate paravalvular regurgitation . Mean follow-up time , based on the last patient contact , was 217±188 days for the transfemoral and 525±413 days for the transapical group . Thirty-day mortality was 2.5 % and 4.0 % , and one-year Kaplan-Meier survival was 94.8 % ( 95 % CI : 87.5 - 97.9 ) and 81.9 % ( 95 % CI : 72.0 - 88.5 ) , respectively . At two years , survival was 64.9 % ( 95 % CI : 52.6 - 74.7 ) for transapical patients . CONCLUSIONS This early single-centre experience showed very good safety and performance outcomes in patients treated with the ACURATE prostheses Abstract OBJECTIVES : The ACURATE TATM system is a self-exp and ing transcatheter heart valve system design ed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials . The SAVI-1 and SAVI-2 registries aim ed to assess whether these promising outcomes can be translated into all-comers clinical routine . METHODS : From November 2011 to 2012 ( SAVI-1 ) , and November 2013 to 2014 ( SAVI-2 ) , a total of 500 patients were enrolled in the prospect i ve , all-comers , multicentre , multinational SAVI registries . Patients were treated according to the st and ard of care at their respective hospitals . We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2 . RESULTS : Patients were 80.8 ± 6.1 years old , the mean logistic EuroSCORE-I was 23.4 ± 14.3 % . Valves were deployed under rapid pacing in 71.3 % of the procedures in SAVI-1 , and in 3.6 % in SAVI-2 . There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2 . Overall mortality at 30 days and 1 year was 6.8 % and 19.9 % , the stroke rate was 2.2 % and 3.7 % , respectively ; 10.2 % of patients had received a permanent pacemaker , and no transcatheter valve-related complications after discharge were observed . Paravalvular leakage ≥2 + was reported in 1.9 % of the patients at the early follow-up , and in 2.6 % at the 1-year follow-up . CONCLUSIONS : The SAVI-registries have confirmed that transapical implantation using the ACURATE TATM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year ; outcomes were similar between SAVI-1 and -2 . Clinical Trials.gov : OBJECTIVES To evaluate balloon-exp and able and self-exp and ing third-generation transcatheter aortic valve replacement ( TAVR ) devices according to patient selection criteria and outcomes . BACKGROUND Two competing third-generation TAVR technologies are currently commercially available in the US . There are no published head-to-head comparisons of the relative performance of these two devices . METHODS 257 consecutive patients undergoing TAVR with a third-generation balloon-exp and able ( Edwards Sapien 3 ) or self-exp and ing device ( Medtronic CoreValve Evolut R ) at a single US medical center were included . Choice of TAVR device was at the discretion of the multidisciplinary Heart Team . Baseline clinical characteristics , echocardiographic and CT imaging , procedural and 30-day outcomes were prospect ively collected . RESULTS 74 patients received a self-exp and ing valve ( SEV ) and 183 received a balloon-exp and able valve ( BEV ) . Patients selected for SEV  were more frequently women , with lower body surface area and smaller calcified iliofemoral arteries . Three SEV patients required implantation of a second valve to successfully treat paravalvular leak . Only one BEV patient had moderate paravalvular regurgitation . There was no difference in the rate of stroke , major vascular complication or bleeding . Permanent pacemaker implantation rate was significantly higher with SEV ( 12.7 % vs 4.7 % , P = 0.49 ) and hospital length of stay was longer ( 8.3 % vs 6.5 % , P = 0.043 ) , but 30-day mortality was comparable ( 1.4 % vs 1.6 % , P = 1.00 ) . CONCLUSIONS Short-term outcomes were equivalent between the two technologies . Clinical ly significant paravalvular regurgitation was rare . SEV were more frequently selected in women and patients with challenging transfemoral access , but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay AIMS Based on r and omized trials using first-generation devices , transcatheter aortic valve replacement ( TAVR ) is well established in the treatment of high-risk ( HR ) patients with severe aortic stenosis ( AS ) . To date , there is a paucity of adjudicated , prospect i ve data evaluating outcomes with newer generation devices and in lower risk patients . We report early outcomes of a large , multicentre registry of inoperable , HR , and intermediate-risk ( IR ) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve ( THV ) .  METHODS AND RESULTS Patients with severe , symptomatic AS ( 583 high surgical risk or inoperable and 1078 IR ) were enrolled in a multicentre , non-r and omized registry at 57 sites in the USA and Canada . All patients received TAVR with the SAPIEN 3 system via transfemoral ( n = 1443 , 86.9 % ) and transapical or transaortic ( n = 218 , 13.1 % ) access routes . The rate of 30-day all-cause mortality was 2.2 % in HR/inoperable patients [ mean Society of Thoracic Surgeons ( STS ) score 8.7 % ] and 1.1 % in IR patients ( mean STS score 5.3 % ) ; cardiovascular mortality was 1.4 and 0.9 % , respectively . In HR/inoperable patients , the 30-day rate of major/disabling stroke was 0.9 % , major bleeding 14.0 % , major vascular complications 5.1 % , and requirement for permanent pacemaker 13.3 % . In IR patients , the 30-day rate of major/disabling stroke was 1.0 % , major bleeding 10.6 % , major vascular complications 6.1 % , and requirement for permanent pacemaker 10.1 % . Mean overall Kansas City Cardiomyopathy Question naire score increased from 47.8 to 67.8 ( HR/inoperable , P < 0.0001 ) and 54.7 to 74.0 ( IR , P < 0.0001 ) . Overall , paravalvular regurgitation at 30 days was none/trace in 55.9 % of patients , mild in 40.7 % , moderate in 3.4 % , and severe in 0.0 % . Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days , while aortic valve area increased from 0.69 to 1.67 cm(2 ) . CONCLUSIONS The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation . TRIAL REGISTRATION Clinical Trials.gov # NCT01314313 BACKGROUND Clinical outcomes in large patient population s from real-world clinical practice with a next-generation self-exp and ing transcatheter aortic valve are lacking . OBJECTIVES This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement ( TAVR ) with a next-generation , self-exp and ing transcatheter heart valve ( THV ) system in patients with severe symptomatic aortic stenosis ( AS ) in routine clinical practice . METHODS The FORWARD ( CoreValve Evolut R FORWARD ) study is a prospect i ve , single-arm , multinational , multicenter , observational study . An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions . An independent echocardiographic core laboratory evaluated all echocardiograms . From January 2016 to December 2016 , TAVR with the next-generation self-exp and ing THV was attempted in 1,038 patients with symptomatic , severe AS at 53 centers on 4 continents . RESULTS Mean age was 81.8 ± 6.2 years , 64.9 % were women , the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5 % , and 33.9 % of patients were deemed frail . The repositioning feature of the THV was applied in 25.8 % of patients . A single valve was implanted in the proper anatomic location in 98.9 % of patients . The mean aortic valve gradient was 8.5 ± 5.6 mm Hg , and moderate or severe aortic regurgitation was 1.9 % at discharge . All-cause mortality was 1.9 % , and disabling stroke occurred in 1.8 % at 30 days . The expected-to-observed early surgical mortality ratio was 0.35 . A pacemaker was implanted in 17.5 % of patients . CONCLUSIONS TAVR using the next-generation THV is clinical ly safe and effective for treating older patients with severe AS at increased operative risk . ( CoreValve Evolut R FORWARD Study [ FORWARD ] ; NCT02592369 ) 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 ) 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 This study sought to present the U.K. experience to date with the second-generation LOTUS bioprosthesis ( Boston Scientific , Natick , Massachusetts ) . BACKGROUND First-generation transcatheter aortic valves have limitations . Second-generation repositionable valves may improve on some of those limitations . METHODS Prospect ively collected data relating to procedural and in-hospital outcome was analyzed from 10 implantation centers in the United Kingdom . RESULTS Implants in 228 patients age 81.4 ± 7.6 years were studied ; 53.5 % were male . Mean logistic EuroScore was 17.5 ± 12.4 . One hundred eighty-seven ( 82.0 % ) were undertaken for aortic stenosis , 7 ( 3.1 % ) for aortic regurgitation , and 34 ( 14.9 % ) for mixed aortic valve disease . A total of 67.1 % of cases were done under local anesthetic and /or sedation with transfemoral access in 94.7 % and transaortic in 5.3 % . Three device sizes were used : 23 mm ( n = 66 , 28.9 % ) , 25 mm ( n = 39 , 17.1 % ) , and 27 mm ( n = 123 , 53.9 % ) . The valve was successfully deployed in 99.1 % of procedures . After implantation , the mean aortic gradient was 11.4 ± 5.4 mm Hg and aortic valve area 1.6 ± 0.5 cm(2 ) . In-hospital mortality was 1.8 % ( n = 4 ) . Complications included cardiac tamponade ( 1.8 % ) , conversion to sternotomy ( 1.3 % ) , stroke ( 3.9 % ) , vascular access-related ( 7.0 % ) , and acute kidney injury ( 7.9 % ) . The incidence of moderate/severe aortic regurgitation was 0.8 % ( n = 2 ) . A total of 31.8 % of patients required new permanent pacemaker implantation . CONCLUSIONS This analysis represents the largest published series on use of the LOTUS valve . Outcomes using this valve are excellent . In-hospital mortality is very low . Complication rates are low , and the LOTUS valve improves on first-generation valves , particularly with regard to residual aortic regurgitation 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 We compared transcatheter aortic-valve replacement ( TAVR ) , using a self-exp and ing transcatheter aortic-valve bioprosthesis , with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery . METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center . Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors . Eligible patients were r and omly assigned in a 1:1 ratio to TAVR with the self-exp and ing transcatheter valve ( TAVR group ) or to surgical aortic-valve replacement ( surgical group ) . The primary end point was the rate of death from any cause at 1 year , evaluated with the use of both noninferiority and superiority testing . RESULTS A total of 795 patients underwent r and omization at 45 centers in the United States . In the as-treated analysis , the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group ( 14.2 % vs. 19.1 % ) , with an absolute reduction in risk of 4.9 percentage points ( upper boundary of the 95 % confidence interval , -0.4 ; P<0.001 for noninferiority ; P = 0.04 for superiority ) . The results were similar in the intention-to-treat analysis . In a hierarchical testing procedure , TAVR was noninferior with respect to echocardiographic indexes of valve stenosis , functional status , and quality of life . Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke . CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk , TAVR with a self-exp and ing transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement . ( Funded by Medtronic ; U.S. CoreValve High Risk Study Clinical Trials.gov number , NCT01240902 . ) BACKGROUND Transcatheter aortic-valve implantation ( TAVI ) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses . We report the results of a prospect i ve multicenter study of the French national transcatheter aortic-valve implantation registry , FRANCE 2 . METHODS All TAVIs performed in France , as listed in the FRANCE 2 registry , were prospect ively included in the study . The primary end point was death from any cause . RESULTS A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers . The mean ( ±SD ) age was 82.7±7.2 years ; 49 % of the patients were women . All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement .  Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9 % and 33.1 % of patients , respectively . Approaches were either transarterial ( transfemoral , 74.6 % ; subclavian , 5.8 % ; and other , 1.8 % ) or transapical ( 17.8 % ) . The procedural success rate was 96.9 % . Rates of death at 30 days and 1 year were 9.7 % and 24.0 % , respectively . At 1 year , the incidence of stroke was 4.1 % , and the incidence of periprosthetic aortic regurgitation was 64.5 % . In a multivariate model , a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation ( EuroSCORE ) , New York Heart Association functional class III or IV symptoms , the use of a transapical TAVI approach , and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival . CONCLUSIONS This prospect i ve registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis , in whom TAVI appeared to be a reasonable option . ( Funded by Edwards Lifesciences and Medtronic . ) Background Conduction disorders 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 OBJECTIVES The aim of this study was : 1 ) to evaluate the acute and late outcomes of a transcatheter aortic valve implantation ( TAVI ) program including both the transfemoral ( TF ) and transapical ( TA ) approaches ; and 2 ) to determine the results of TAVI  in patients deemed inoperable because of either porcelain aorta or frailty . BACKGROUND Very few data exist on the results of a comprehensive TAVI program including both TA and TF approaches for the treatment of severe aortic stenosis in patients at very high or prohibitive surgical risk . METHODS Consecutive patients who underwent TAVI with the Edwards valve ( Edwards Lifesciences , Inc. , Irvine , California ) between January 2005 and June 2009 in 6 Canadian centers were included . RESULTS A total of 345 procedures ( TF : 168 , TA : 177 ) were performed in 339 patients . The predicted surgical mortality ( Society of Thoracic Surgeons risk score ) was 9.8 + /- 6.4 % . The procedural success rate was 93.3 % , and 30-day mortality was 10.4 % ( TF : 9.5 % , TA : 11.3 % ) . After a median follow-up of 8 months ( 25th to 75th interquartile range : 3 to 14 months ) the mortality rate was 22.1 % . The predictors of cumulative late mortality were peri-procedural sepsis ( hazard ratio [ HR ] : 3.49 , 95 % confidence interval [ CI ] : 1.48 to 8.28 ) or need for hemodynamic support ( HR : 2.58 , 95 % CI : 1.11 to 6 ) , pulmonary hypertension ( PH ) ( HR : 1.88 , 95 % CI : 1.17 to 3 ) , chronic kidney disease ( CKD ) ( HR : 2.30 , 95 % CI : 1.38 to 3.84 ) , and chronic obstructive pulmonary disease ( COPD ) ( HR : 1.75 , 95 % CI : 1.09 to 2.83 ) . Patients with either porcelain aorta ( 18 % ) or frailty ( 25 % ) exhibited acute outcomes similar to the rest of the study population , and porcelain aorta patients tended to have a better survival rate at 1-year follow-up . CONCLUSIONS A TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for the treatment of patients at very high or prohibitive surgical risk , including porcelain aorta and frail patients . Baseline ( PH , COPD , CKD ) and peri-procedural ( hemodynamic support , sepsis ) factors but not the approach determined worse outcomes 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 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 OBJECTIVES The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system . BACKGROUND The Portico transcatheter aortic heart valve is a fully resheathable , repositionable , and self-exp and ing bioprosthesis design ed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances . METHODS Patients ( n = 222 ) with symptomatic ( New York Heart Association functional class ≥II ) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospect i ve , nonr and omized , multicenter study . Patients were implanted with the full range of Portico heart valves  ( 23 , 25 , 27 , and 29 mm ) using the transfemoral approach . The primary endpoint was all-cause mortality at 30 days . Secondary endpoints included valve performance , improvement in functional class , and procedural outcomes as defined by Valve Academic Research Consortium criteria . RESULTS A total of 220 patients ( mean age 83.0 ± 4.6 years , 74.3 % women , mean Society of Thoracic Surgeons score 5.8 % ) had valves implanted . All resheathing and repositioning attempts ( n = 72 ) were successful . At 30 days , all-cause mortality was 3.6 % . Procedural outcomes included disabling ( major ) stroke ( 3.2 % ) , major vascular complications ( 7.2 % ) , and permanent pacemaker implantation ( 13.5 % ) . Compared with baseline , 75.8 % of patients improved by ≥1 New York Heart Association functional class at 30 days . The rate of moderate paravalvular leak was 5.7 % , with no severe paravalvular leak reported . No differences in paravalvular leak incidence and severity were observed among valve sizes ( p = 0.24 ) . CONCLUSIONS Across all valve sizes , use of the repositionable Portico transcatheter aortic valve replacement system result ed in safe and effective treatment of aortic stenosis in 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 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 OBJECTIVES The study sought a prospect i ve multicenter nonr and omized evaluation of the Direct Flow Medical ( DFM ) system for the treatment of severe aortic stenosis . BACKGROUND The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning , retrieval , and assessment of valve performance prior to permanent implantation . METHODS One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint . There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase .  Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium ( VARC ) criteria . RESULTS There was 99 % freedom from all cause mortality at 30 days ( primary endpoint ) . VARC criteria defined 30 day combined freedom from patient safety event rate was 91 % and overall device success was 93 % . The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99 % ( 73 of 74 ) with a mean gradient of 12.6 ± 7.1 mm Hg ( n = 72 ) and effective orifice area of 1.50 ± 0.56 cm(2 ) and New York Heart Association functional class was I or II in 92 % of cases . CONCLUSIONS The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99 % of patients BACKGROUND The SAPIEN 3 ( Edwards Lifesciences Inc. , Irvine , California ) transcatheter valve incorporates features design ed to address the well-known deficiencies of transcatheter aortic valve replacement ( TAVR ) . An ultra-low-profile delivery system facilitates safe , controlled , and accurate implantation and an external seal minimizes paravalvular regurgitation . OBJECTIVES The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis . METHODS The prospect i ve study enrolled 150 patients at 16 sites in Europe and Canada .  Clinical and echocardiographic outcomes were assessed at baseline , post-procedure , and 30 days . New sizing recommendations were developed during the course of the study . RESULTS Patients were 83.6 ± 5.0 years of age , with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5 % and logistic EuroSCORE of 21.6 ± 12.3 % . A transfemoral approach was chosen in 64.0 % and alternative access ( transapical/direct aortic ) in the remainder . At 30 days , paravalvular regurgitation was none to mild in 96.4 % and moderate in 3.5 % . No patient had severe regurgitation . Transfemoral implantation was associated with low mortality ( 2.1 % ) , no disabling stroke ( 0.0 % ) , and fully percutaneous access and closure in 95.8 % . Nontransfemoral alternative access was associated with higher rates of mortality ( 11.6 % ) and stroke ( 5.6 % ) . CONCLUSIONS This third-generation device addresses major deficiencies of earlier valves in terms of ease of use , accuracy of positioning , and paravalvular sealing . The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients . ( Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [ SAPIEN3 ] ; NCT01808287 ) OBJECTIVES This study sought to develop a robust and definitive risk model for new permanent pacemaker implantation ( PPMI ) after SAPIEN 3 ( third generation balloon exp and able valve )  ( Edwards Lifesciences , Irvine , California ) transcatheter aortic valve replacement ( third generation balloon exp and able valve TAVR ) , including calcification in the aortic-valvular complex ( AVC ) . BACKGROUND The association between calcium in the AVC and need for PPMI is poorly delineated after third generation balloon exp and able valve TAVR . METHODS At Cedars-Sinai Heart Institute in Los Angeles , California , a total of 240 patients with severe aortic stenosis underwent third generation balloon exp and able valve TAVR and had contrast computed tomography .  AVC was characterized precisely by leaflet sector and region . RESULTS The total new PPMI rate was 14.6 % . On multivariate analysis for predictors of PPMI , pre-procedure third generation balloon exp and able valve TAVR , right bundle branch block ( RBBB ) , shorter membranous septum ( MS ) length , and noncoronary cusp device-l and ing zone calcium volume ( NCC-DLZ CA ) were included . Predictive probabilities were generated using this logistic regression model . If 3 pre-procedural risk factors were present , the c-statistic of the model for PPMI was area under the curve of 0.88 , sensitivity of 77.1 % , and specificity of 87.1 % ; this risk model had high negative predictive value ( 95.7 % ) . The addition of the procedural factor of device depth to the model , with the parameter of difference between implantation depth and MS length , combined with RBBB and NCC-DLZ CA increased the c-statistic to 0.92 , sensitivity to 94.3 % , specificity to 83.8 % , and negative predictive value to 98.8 % CONCLUSIONS : By using a precise characterization of distribution of calcification in the AVC in a single-center , retrospective study , NCC-DLZ CA was found to be an independent predictor of new PPMI post-third generation balloon exp and able valve TAVR . The findings also reinforce the importance of short MS length , pre-existing RBBB , and ventricular implantation depth as important synergistic PPMI risk factors . This risk model will need validation by future prospect i ve multicenter studies OBJECTIVES Transcatheter aortic valve replacement ( TAVR ) is an established therapy for patients with aortic stenosis ( AS ) at high surgical risk .  The JenaValve ™ is a second-generation , self-exp and ing transcatheter heart valve ( THV ) , implanted through transapical access ( TA ) . During stent deployment , a specific ' clipping-mechanism ' engages native aortic valve cusps for fixation . We present 1-year outcomes of the JUPITER registry , a post-market registry of the JenaValve for TA-TAVR . METHODS The JUPITER registry is a prospect i ve , multicentre , uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV . A total of 180 patients with AS were enrolled between 2012 and 2014 . End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions . RESULTS The mean age was 80.4 ± 5.9 years and the mean logistic  European system for cardiac operative risk evaluation I 21.2 ± 14.7 % . The procedure was successful in 95.0 % ( 171/180 ) , implantation of a second THV ( valve-in-valve ) was performed in 2.2 % ( 4/180 ) and conversion to surgical aortic valve replacement ( SAVR ) was necessary in 2.8 % ( 5/180 ) . No annular rupture or coronary ostia obstruction occurred . Two patients required SAVR after the day of index procedure ( 1.1 % ) . All-cause mortality at 30 days was 11.1 % ( 20/180 ) , being cardiovascular in 7.2 % ( 13/180 ) . A major stroke occurred in 1.1 % ( 2/180 ) at 30 days , no additional major strokes were observed during 1 year . All-cause mortality after 30 days was 13.1 % ( 21/160 ) and combined efficacy at 1 year was 80.8 % ( 122/151 ) . At 1-year follow-up , no patient presented with more than moderate paravalvular leakage , while 2 patients ( 3.2 % ) showed moderate , 12 ( 19.0 % ) mild and 49 ( 82.4 % ) trace/none paravalvular regurgitation . CONCLUSIONS In a high-risk cohort of patients undergoing TA-TAVR  for AS , the use of the JenaValve THV is safe and effective . In patients at higher risk for coronary ostia obstruction , annular rupture or with limited aortic valve calcification , the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-exp and ing stent 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 We report clinical outcomes following transcatheter aortic valve implantation ( TAVI ) , using the CoreValve revalving system ( 18 Fr transfemoral or subclavian ) or the Edwards Sapien valve ( 22 Fr transfemoral or 24 Fr transapical ) as part of a Belgian prospect i ve non-r and omized multicentre registry . All 15 Belgian centres performing TAVI  participated to this registry ( seven exclusively Edwards Sapien , eight exclusively CoreValve ) . All consecutive high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVI . Three hundred and twenty-eight patients underwent TAVI with CoreValve ( n = 141 ; eight subclavian and 133 transfemoral ) or Edwards Sapien ( n = 187 ; 99 transfemoral and 88 transapical ) up to April 2010 .  Procedural success was 97 % . One-month survival was 88 % for the Edwards and 89 % for the CoreValve treated patients . One-month mortality was both related to cardiac and non-cardiac reasons . Overall one-year survival was 78 % in the CoreValve transfemoral treated patients , 100 % in the CoreValve subclavian treated patients , 82 % in the Edwards transfemoral treated patients and 63 % in the Edwards transapical treated patients . This mid-term mortality was mainly related to age-related , non-cardiac complications BACKGROUND Previous trials have shown that among high-risk patients with aortic stenosis , survival rates are similar with transcatheter aortic-valve replacement ( TAVR ) and surgical aortic-valve replacement . We evaluated the two procedures in a r and omized trial involving intermediate-risk patients . METHODS We r and omly assigned 2032 intermediate-risk patients with severe aortic stenosis , at 57 centers , to undergo either TAVR or surgical replacement . The primary end point was death from any cause or disabling stroke at 2 years . The primary hypothesis was that TAVR would not be inferior to surgical replacement . Before r and omization , patients were entered into one of two cohorts on the basis of clinical and imaging findings ; 76.3 % of the patients were included in the transfemoral-access cohort and 23.7 % in the transthoracic-access cohort . RESULTS The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group ( P=0.001 for noninferiority ) . At 2 years , the Kaplan-Meier event rates were 19.3 % in the TAVR group and 21.1 % in the surgery group ( hazard ratio in the TAVR group , 0.89 ; 95 % confidence interval [ CI ] , 0.73 to 1.09 ; P=0.25 ) . In the transfemoral-access cohort , TAVR result ed in a lower rate of death or disabling stroke than surgery ( hazard ratio , 0.79 ; 95 % CI , 0.62 to 1.00 ; P=0.05 ) , whereas in the transthoracic-access cohort , outcomes were similar in the two groups . TAVR result ed in larger aortic-valve areas than did surgery and also result ed in lower rates of acute kidney injury , severe bleeding , and new-onset atrial fibrillation ; surgery result ed in fewer major vascular complications and less paravalvular aortic regurgitation . CONCLUSIONS In intermediate-risk patients , TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke . ( Funded by Edwards Lifesciences ; PARTNER 2 Clinical Trials.gov number , NCT01314313 . ) Background Although transcatheter aortic‐valve replacement ( TAVR ) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk , less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk . Methods We evaluated the clinical outcomes in intermediate‐risk patients with severe , symptomatic aortic stenosis in a r and omized trial comparing TAVR ( performed with the use of a self‐exp and ing prosthesis ) with surgical aortic‐valve replacement . The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic‐valve replacement . We used Bayesian analytical methods ( with a margin of 0.07 ) to evaluate the noninferiority of TAVR as compared with surgical valve replacement . Results A total of 1746 patients underwent r and omization at 87 centers . Of these patients , 1660 underwent an attempted TAVR or surgical procedure . The mean ( ±SD ) age of the patients was 79.8±6.2 years , and all were at intermediate risk for surgery ( Society of Thoracic Surgeons Predicted Risk of Mortality , 4.5±1.6 % ) . At 24 months , the estimated incidence of the primary end point was 12.6 % in the TAVR group and 14.0 % in the surgery group ( 95 % credible interval [ Bayesian analysis ] for difference , ‐5.2 to 2.3 % ; posterior probability of noninferiority , > 0.999 ) . Surgery was associated with higher rates of acute kidney injury , atrial fibrillation , and transfusion requirements , whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation  . TAVR result ed in lower mean gradients and larger aortic‐valve areas than surgery . Structural valve deterioration at 24 months did not occur in either group . Conclusions TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk , with a different pattern of adverse events associated with each procedure . ( Funded by Medtronic ; SURTAVI Clinical Trials.gov number , NCT01586910 . 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 This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve ( THV ) for the treatment of severe aortic stenosis in patients at extreme risk for surgery . BACKGROUND Untreated severe aortic stenosis is a progressive disease with a poor prognosis . Transcatheter aortic valve replacement ( TAVR ) with a self-exp and ing bioprosthesis is a potentially effective therapy . METHODS We performed a prospect i ve , multicenter , nonr and omized investigation evaluating the safety and efficacy of self-exp and ing TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery . The primary endpoint was a composite of all-cause mortality or major stroke at 12 months , which was compared with a pre-specified objective performance goal ( OPG ) . RESULTS A total of 41 sites in the United States recruited 506 patients , of whom 489 underwent attempted treatment with the CoreValve THV .  The rate of all-cause mortality or major stroke at 12 months was 26.0 % ( upper 2-sided 95 % confidence bound : 29.9 % ) versus 43.0 % with the OPG ( p < 0.0001 ) . Individual 30-day and 12-month events included all-cause mortality ( 8.4 % and 24.3 % , respectively ) and major stroke ( 2.3 % and 4.3 % , respectively ) . Procedural events at 30 days included life-threatening/disabling bleeding ( 12.7 % ) , major vascular complications ( 8.2 % ) , and need for permanent pacemaker placement ( 21.6 % ) . The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-exp and ing TAVR ( 4.2 % ) than at discharge ( 10.7 % ; p = 0.004 for paired analysis ) . CONCLUSIONS TAVR with a self-exp and ing bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement . ( Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement ; NCT01240902 ) 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 OBJECTIVES The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve . BACKGROUND The Evolut R is a self-exp and ing , repositionable , and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications . METHODS Clinical , procedural , and 30-day outcome data were prospect ively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Irel and . RESULTS A total of 264 consecutive Evolut R implantations were performed across 9 centers . The mean age was 81.1 ± 7.8 years , and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7 % . Procedural indications included aortic stenosis ( 72.0 % ) , mixed aortic valve disease ( 17.4 % ) , and failing aortic valve bioprostheses ( 10.6 % ) . Conscious sedation was used in 39.8 % of patients and transfemoral access in 93.6 % . The procedural success rate was 91.3 % , and paravalvular leak immediately after implantation was mild or less in 92.3 % . Major complications were rare : cardiac tamponade in 0.4 % , conversion to sternotomy in 0.8 % , annular rupture in 0.0 % , coronary occlusion in 0.8 % , major vascular in 5.3 % , acute kidney injury in 6.1 % , new permanent pacemaker implantation in 14.7 % , and procedure-related death in 0.0 % . At 30-day follow-up , survival was 97.7 % , paravalvular leak was mild or less in 92.3 % , and the stroke rate was 3.8 % . CONCLUSIONS This registry represents the largest published real-world experience of the Evolut R valve . The procedural success rate was high and safety was excellent , comparable with previous studies of the Evolut R valve and other second-generation devices . The low rate of complications represents an improvement on first-generation devices 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
target: 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
background: 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 .