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Aim: To assess the outcome of nonagenarians patients receiving transcatheter aortic valve replacement (TAVR)., Methods: We aimed to stratify the overall population from an Italian, multicenter, observational project including a total of 3792 consecutive patients who underwent TAVR with CoreValve and Evolut R/PRO devices between April 2009 and October 2018, into four groups according to their age class (≥90 vs. 80-89 years vs. 70-79 vs. <70 years) and to compare outcomes up to 4 years after TAVR., Results: At 4 years, survival estimates showed no difference in terms of overall survival [Kaplan-Meier estimates (KM est.) 49.9 vs. 58.1% vs. 57.0 vs. 69.3%; Plogrank = 0.28] among the four groups. After 2 years from the procedure, landmark analysis showed an age-based difference in overall survival (KM est. 63.8 vs. 75.0% vs. 75.1 vs. 88.7%; Plogrank = 0.025) but no difference in terms of survival from cardiovascular death (KM est. 87.8 vs. 87.4% vs. 86.1 vs. 96.1%; Plogrank = 0.43). Finally, age itself was not correlated with overall mortality at 4 years (hazard ratio 1.06, 95% confidence interval 0.86-1.30, P = 0.591)., Conclusion: TAVR with self-expanding CoreValve and Evolut prostheses was demonstrated to have good long-term outcomes, regardless of the patient's age. At 4 years, no difference in overall mortality was reported among age-based groups, while a higher overall mortality was reported in nonagenarians after 2 years from the procedure. TAVR showed good long-term outcomes even in nonagenarian patients, and it could be the therapy of choice for selected elderly patients., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement., Methods: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days., Results: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P =0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P =0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P =0.03) and 1 year (8.4% versus 3.9%; P =0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P =0.002) were significantly increased in the ACURATE neo group., Conclusions: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.

Background: Large data comparing the performance of new-generation self-expandable versus balloon-expandable transcatheter heart valves in bicuspid aortic stenosis are lacking. We aim to compare the safety and performance of balloon-expandable and self-expandable transcatheter heart valves in the treatment of bicuspid aortic stenosis., Methods: The BEAT (balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis) registry included 353 consecutive patients who underwent transcatheter aortic valve implantation using new-generation Evolut R/PRO or Sapien 3 valves in bicuspid aortic valve., Results: A total of 353 patients (n=242 [68.6%] treated with Sapien 3 and n=111 [68.6%] treated with Evolut R (n=70)/PRO [n=41]) were included. Mean age was 77.8±8.3 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality was 4.4±3.3%. Valve Academic Research Consortium-2 device success was similar between Sapien 3 and Evolut R/PRO (85.6% versus 87.2%; P =0.68). In the Sapien 3 group, 4 patients experienced annular rupture whereas this complication did not occur in the Evolut R/PRO group. After propensity score matching, Valve Academic Research Consortium-2 device success was similar between both groups (Sapien 3=85.7% versus Evolut R/Pro=84.4%; P =0.821). Both in the overall and in the matched population, no differences in the rate of permanent pacemaker implant were observed. At 1-year follow-up, the rate of overall death and cardiovascular death were similar between the 2 groups. In the unmatched population, the 1-year echocardiographic follow-up demonstrated similar rate of moderate-to-severe paravalvular aortic regurgitation (Evolut R/PRO 10.5% versus Sapien 3 4.2%, P =0.077); however, after propensity matching, the rate of moderate-to-severe paravalvular leak became significantly higher among patients treated with self-expandable valves (9.3% versus 0%; P =0.043)., Conclusions: Our study confirms the feasibility of both Sapien 3 and Evolut R/PRO implantation in bicuspid aortic valve anatomy; a higher rate of moderate-severe paravalvular aortic regurgitation was observed in the Evolut R/PRO group at 1-year follow-up in the matched cohort, although patients treated with balloon-expandable valve had a higher rate of annular rupture.

Objectives: We aimed to analyze the baseline features and clinical outcomes of patients younger than 80 years undergoing transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) real-world study, focusing on variables guiding Heart Team decision toward TAVI., Background: Patients treated with TAVI, independently of surgical risk score, are mostly older than 80 years., Methods: OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis (AS) who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. For this analysis, baseline characteristics, therapeutic approach and outcomes up to 5 years of follow-up of 4,801 patients under 80 years of age were collected. Patients were stratified by age classes (<65, 65-74, and 75-79 years)., Results: Patients <80 years of age with severe symptomatic AS undergoing TAVI (n = 483) had significantly higher Logistic EuroSCORE (10.84% vs. 5.22%, p < .001) and prevalence of comorbidities compared to subjects undergoing SAVR (n = 4,318). The decision to perform TAVI over SAVR was driven by anatomical factors, mainly previous cardiac surgery (odds ratio [OR] 24.73, confidence interval [CI] 12.71-48.10, p < .001) and the presence of porcelain aorta (OR 17.44, CI 6.67-45.55, p < .001), and clinical factors, mainly moderate-severe frailty score (OR 5.49, CI 3.33-9.07, p < .001), oxygen dependency (OR 7.42, CI 2.75-20.04, p < .001) and need for dialytic treatment (OR 5.24, CI 1.54-17.80, p < .008). Among patients undergoing TAVI, those under 65 years had the highest baseline risk profile (despite a low Logistic EuroSCORE) and the highest 5-year mortality compared to those 65-74 and 75-79-year-old (65.22% vs. 48.54% vs. 55.24%, log-rank p = .061)., Conclusion: Among patients under 80 years of age with symptomatic severe AS, only 10% underwent TAVI. These patients were at higher baseline risk compared to those undergoing SAVR. The decision to perform TAVI was driven by the presence of both anatomical and clinical factors beyond surgical risk scores. Patients under 65 years of age, despite the low Logistic EuroSCORE, had the highest preoperative risk profile and carried the worse outcome., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR)., Background: Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality., Methods: Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019., Results: Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19)., Conclusions: In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF-TAVI) using three different new-generation devices., Background: Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head-to-head comparisons are available among these devices., Methods: This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF-TAVI for native, severe aortic stenosis using a new-generation transcatheter aortic valve (TAV) with a preprocedural multi-detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method., Results: The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30-day all-cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p < .05). At 30 days, patients treated with SAPIEN 3 valve showed a higher mean transvalvular gradient (9.7 ± 7.5 mmHg vs. 6.1 ± 2.4 mmHg vs. 8.4 ± 3.5 mmHg for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01) and a lower rate of more-than-trace paravalvular regurgitation (PVR) (18.8 vs. 47.9 vs. 45.8%, for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01). At 1 year, SAPIEN 3, Evolut R, and ACURATE neo TAVs showed excellent and comparable outcomes with no difference in terms of freedom from major adverse cardiovascular and cerebrovascular event (MACCE) (p log-rank = 0.534)., Conclusions: TAVI using new-generation prostheses was associated with high device success (97.0% vs. 92.8% vs. 95.0% for SAPIEN 3, Evolut R and ACURATE neo, respectively) and low complications rates up to 1 year. Evolut R valve was associated with a higher rate of PPI whereas SAPIEN 3 valve was associated with a higher mean transvalvular gradient and lower rate of more-than-trace PVR. At 1-year, MACCE rates were similar among the three groups., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli., Background: Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli., Methods: TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm 2 on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch., Results: Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm 2 /m 2 (95% CI: 1.01 to 1.08 cm 2 /m 2 ) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups., Conclusions: Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction : Transcatheter aortic valve implantation (TAVI) is the treatment of choice for a large proportion of patients with severe aortic stenosis. Despite numerous technological and clinical advances, TAVI remains associated with thrombotic complications requiring antithrombotic pharmacotherapy, which exposes to the risk of bleeding, especially in elderly individuals. The optimal antithrombotic regimen following TAVI is uncertain and several investigations are ongoing. Areas covered : Clinical guidelines are mostly driven by observational trials and experts' opinions, thus resulting into low-grade level of evidence. The aim of the current review is to critically explore the epidemiology, pathophysiology and prognostic value of thrombotic and bleeding events after TAVI, and to review the current literature on antithrombotic strategies following the procedure. Expert opinion : Thrombotic and bleeding events remain major complications occurring in the frail population that is currently offered TAVI. Waiting for upcoming evidence from ongoing randomized clinical trials, tailoring antithrombotic therapies based on patients' characteristics, values and circumstances is a preferable approach.

Background: The OBSERVANT study (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study., Methods and Results: The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary end points of this analysis were death from any cause and major adverse cardiac and cerebrovascular events at 5 years. The matched population had a total of 1300 patients (650 per group). The propensity score method generated a low and intermediate-risk population (mean logistic EuroSCORE 2: 5.1±6.2% versus 4.9±5.1%, SAVR versus transfemoral TAVR; P=0.485). At 5 years, the rate of 5 death from any cause was 35.8% in the surgical group and 48.3% in the transcatheter group (hazard ratio, 1.38; 95% CI, 1.12-1.69; P=0.002). Similarly, TAVR was associated with an increased risk of major adverse cardiac and cerebrovascular events as compared with SAVR (42.5% versus 54.0%; hazard ratio, 1.35; 95% CI, 1.11-1.63; P=0.003). The cumulative incidence of cerebrovascular events, myocardial infarction, and coronary revascularization were similar in the study groups at 5 years., Conclusions: The present results suggest that at 5 years, in a real-world population with severe aortic stenosis and at low and intermediate risk, suggest that SAVR is associated in with lower mortality and major adverse cardiac and cerebrovascular events rates than transfemoral TAVR performed using first-generation devices. These data need to be confirmed in randomized trials using new-generation TAVR devices.

Background: Transcatheter aortic valve replacement (TAVR) is a well-established treatment option for severe aortic stenosis (AS). AS and coronary artery disease frequently coincide, and therefore some patients may require coronary angiography (CAG) and/or intervention (PCI) post-TAVR. Due to valve stent design, most self-expanding prostheses always cover the coronary ostium, and therefore may hinder future access. The objective of this research was to evaluate the incidence, safety and feasibility of CAG/PCI in patients with prior self-expanding TAVR valves., Methods: Among 2170 patients (age 82 ± 6 years, 43% male) who underwent TAVR with Corevalve or Evolut prostheses, as part of the Italian CoreValve ClinicalService® framework (data from 13 Italian centers), the occurrence of CAG/PCI following TAVR and periprocedural characteristics were examined., Results: During median follow-up of 379 days, 41 patients (1.9%) required CAG and/or PCI (total 46; 16 CAG, 14 PCI, 16 both PCI/CAG). 56.5% of the procedures were performed under emergency/urgency settings. Left system coronary angiography was successfully performed in most cases (28/32, 87.5%), while right coronary angiography was successful only in 50.0% (16/32). PCI procedures (20 for left system, 3 for right system, 4 for graft) were successfully performed in 93.3% (28/30) of the procedures. No CAG/PCI procedure-related complications including prosthesis dislodgment or coronary ostium dissection occurred., Conclusions: CAG and PCI procedures following CoreValve TAVR is safe and mostly feasible, although the success rate of selective right coronary angiography was relatively low when compared to the left system. Further investigations are required to explore this issue., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices., Background: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR., Methods: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles., Results: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation., Conclusions: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: The authors sought to collect data on contemporary practice and outcome of transcatheter aortic valve replacement (TAVR) in oncology patients with severe aortic stenosis (AS)., Background: Oncology patients with severe AS are often denied valve replacement. TAVR may be an emerging treatment option., Methods: A worldwide registry was designed to collect data on patients who undergo TAVR while having active malignancy. Data from 222 cancer patients from 18 TAVR centers were compared versus 2,522 "no-cancer" patients from 5 participating centers. Propensity-score matching was performed to further adjust for bias., Results: Cancer patients' age was 78.8 ± 7.5 years, STS score 4.9 ± 3.4%, 62% men. Most frequent cancers were gastrointestinal (22%), prostate (16%), breast (15%), hematologic (15%), and lung (11%). At the time of TAVR, 40% had stage 4 cancer. Periprocedural complications were comparable between the groups. Although 30-day mortality was similar, 1-year mortality was higher in cancer patients (15% vs. 9%; p < 0.001); one-half of the deaths were due to neoplasm. Among patients who survived 1 year after the TAVR, one-third were in remission/cured from cancer. Progressive malignancy (stage III to IV) was a strong mortality predictor (hazard ratio: 2.37; 95% confidence interval: 1.74 to 3.23; p < 0.001), whereas stage I to II cancer was not associated with higher mortality compared with no-cancer patients., Conclusions: TAVR in cancer patients is associated with similar short-term but worse long-term prognosis compared with patients without cancer. Among this cohort, mortality is largely driven by cancer, and progressive malignancy is a strong mortality predictor. Importantly, 85% of the patients were alive at 1 year, one-third were in remission/cured from cancer. (Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis [TOP-AS]; NCT03181997)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The impact of preexisting left bundle branch block (LBBB) in transcatheter aortic valve replacement (TAVR) recipients is unknown. The aim of this study was to determine the impact of preexisting LBBB on clinical outcomes after TAVR., Methods and Results: This multicenter study evaluated 3404 TAVR candidates according to the presence or absence of LBBB on baseline ECG. TAVR complications and causes of death were defined according to Valve Academic Research Consortium-2 definitions. Follow-up outpatient visits or telephone interviews were conducted at 30 days, 12 months, and yearly thereafter. Echocardiography examinations were performed at baseline, at hospital discharge, and at 1-year follow-up. Preexisting LBBB was present in 398 patients (11.7%) and was associated with an increased risk of permanent pacemaker implantation (PPI; 21.1% versus 14.8%; adjusted odds ratio, 1.51; 95% CI, 1.12-2.04) but not death (7.3% versus 5.5%; adjusted odds ratio, 1.33; 95% CI, 0.84-2.12) at 30 days. At a mean follow-up of 22±21 months, there were no differences between patients with and without preexisting LBBB in overall mortality (adjusted hazard ratio, 0.94; 95% CI, 0.75-1.18) and cardiovascular mortality (adjusted hazard ratio, 0.90; 95% CI, 0.68-1.21). In a subanalysis of 2421 patients without PPI at 30 days and with complete follow-up about the PPI, preexisting LBBB was not associated with an increased risk of PPI or sudden cardiac death. Patients with preexisting LBBB had a lower left ventricular ejection fraction (LVEF) at baseline and at 1-year follow-up ( P <0.001 for both), but those with low LVEF exhibited a similar increase in LVEF over time after TAVR compared with patients with no preexisting LBBB ( P=0.327)., Conclusions: Preexisting LBBB significantly increased the risk of early (but not late) PPI after TAVR, without any significant effect on overall mortality or cardiovascular mortality. Preexisting LBBB was associated with lower LVEF pre-TAVR but did not prevent an increase in LVEF post-TAVR similar to patients without LBBB.

Background: Transcatheter aortic valve implantation (TAVI) is now the standard treatment for severe aortic stenosis in high-risk symptomatic patients, and its indications are expanding to lower-risk patients., Objectives: The objective of this study was to analyze the state of TAVI in Spain vs other European and non-European countries., Methods: Using an online questionnaire, we analyzed the routine practice of 250 TAVI centers worldwide. The questionnaire included 59 questions on patient selection, technical aspects of the procedure, and postprocedural management. The centers were divided into Spain (n = 41), rest of Europe (n = 105), and rest of the world (n = 104)., Results: The cumulative number of procedures (74; range, 40-122) and those performed in the last year (16.5; range, 15-29.5) in Spain, were significantly lower than the rest of Europe (P<.01) and the rest of the world (P<.01). The patient risk profile was higher, with an under-use of functional tests compared to the rest of the world. While the use of computed tomography to analyze the aortic annulus was lower in Spain (P<.001), general anesthesia and transesophageal echocardiography were more frequently used in Spain than in the rest of Europe (P<.001 for both). Dual-antiplatelet therapy is the most common post-TAVI antithrombotic therapy in the absence of an indication for anticoagulation, although its duration is longer in Spain (6 months) compared to European centers (3 months)., Conclusions: Routine TAVI practice in Spain differed in some key aspects of preprocedural, intraprocedural, and postprocedural management. Future studies will help to unify strategies and assess their impact on clinical results.

To compare dual antiplatelet therapy (DAPT) versus single antiplatelet therapy (SAPT) as antithrombotic treatment after transcatheter aortic valve implantation (TAVI) for the prevention of ischemic events, vascular and bleeding events, and death. Data from the 3 randomized trials comparing DAPT versus SAPT post-TAVI were pooled and analyzed in a patient-level meta-analysis. The primary end point was the occurrence of death, major or life-threatening bleedings, and major vascular complications at 30-day follow-up. Events were adjudicated according to the Valve Academic Research Consortium 2 definitions. A total of 421 patients randomized to DAPT (210 patients) or SAPT (211 patients) post-TAVI were analyzed. There were no differences between groups in baseline clinical and procedural characteristics. The occurrence of the 30-day combined primary end point was higher in the DAPT group (17.6% vs 10.9%, odds ratio 1.73, 95% confidence interval 1.00 to 2.98, p = 0.050), with an increased rate of major or life-threatening bleeding events in the DAPT group (11.4% vs 5.2%, odds ratio 2.24, 95% confidence interval 1.12 to 4.46, p = 0.022). There were no differences between DAPT and SAPT groups in the incidence of death (5.2% vs 3.8%, p = 0.477), global ischemic events (3.8% vs 3.8%, p = 0.999), or stroke (2.4% vs 2.4%, p = 0.996). DAPT (vs SAPT) was associated with a higher rate of major adverse events after TAVI, mainly driven by an increased risk of major or life-threatening bleeding complications along with a lack of beneficial effect on ischemic events. These results do not support the current recommendation of DAPT as antithrombotic therapy after TAVI., (Copyright © 2018 Elsevier Inc. All rights reserved.)

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Background: Chronic liver disease is a known risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery. Very little data exist about such patients treated with transcatheter aortic valve replacement (TAVR). Our objective was to evaluate early and late clinical outcomes in a large cohort of patients with liver disease undergoing TAVR and to determine predictive factors of mortality among these patients., Methods and Results: This multicenter study collected data from 114 patients with chronic liver disease who underwent TAVR in 12 institutions. Perioperative and long-term outcomes were compared with a cohort of 1118 patients without liver disease after a propensity score-matching analysis (114 matched pairs). In-hospital mortality and vascular and bleeding complications were similar between matched groups. Acute kidney injury was more common in liver disease group (30.8% versus 13.5%; P =0.010). Although cardiovascular mortality was similar between groups (9.4% versus 6.5%; P =0.433) at 2-year follow-up, noncardiac mortality was higher in the liver group (26.4% versus 14.8%; P =0.034). Lower glomerular filtration rate (hazard ratio, 1.10, for each decrease of 5 mL/min in estimated glomerular filtration rate; 95% confidence interval, 1.03-1.17; P =0.005) and Child-Pugh class B or C (hazard ratio, 3.11; 95% confidence interval, 1.47-6.56; P =0.003) were the predictors of mortality in patients with chronic liver disease, with a mortality rate of 83.2% at 2-year follow-up in patients with both factors (estimated glomerular filtration rate <60 mL/min and Child-Pugh B or C)., Conclusions: These findings suggested that TAVR is a feasible treatment for severe aortic stenosis in patients with early-stage liver disease or as bridge therapy before a curative treatment of the hepatic condition. Patients with Child-Pugh class B-C, especially in combination with renal impairment, had a very low survival rate, and TAVR should be carefully considered to avoid a futile treatment. These results may contribute to improve the clinical decision-making process and management in patients with liver disease., (© 2018 American Heart Association, Inc.)

Objectives: This study sought to evaluate the long-term clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR)., Background: Conduction disturbances leading to PPI are common following TAVR. However, no data exist regarding the impact of PPI on long-term outcomes post-TAVR., Methods: This was a multicenter study including a total of 1,629 patients without prior PPI undergoing TAVR (balloon- and self-expandable valves in 45% and 55% of patients, respectively). Follow-up clinical, echocardiographic, and pacing data were obtained at a median of 4 years (interquartile range: 3 to 5 years) post-TAVR., Results: PPI was required in 322 (19.8%) patients within 30 days post-TAVR (26.9% and 10.9% in patients receiving self- and balloon-expandable CoreValve and Edwards systems, respectively). Up to 86% of patients with PPI exhibited pacing >1% of the time during follow-up (>40% pacing in 51% of patients). There were no differences between patients with and without PPI in total mortality (48.5% vs. 42.9%; adjusted hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 0.95 to 1.39; p = 0.15) and cardiovascular mortality (14.9% vs. 15.5%, adjusted HR: 0.93; 95% CI: 0.66 to 1.30; p = 0.66) at follow-up. However, patients with PPI had higher rates of rehospitalization due to heart failure (22.4% vs. 16.1%; adjusted HR: 1.42; 95% CI: 1.06 to 1.89; p = 0.019), and the combined endpoint of mortality or heart failure rehospitalization (59.6% vs. 51.9%; adjusted HR: 1.25; 95% CI: 1.05 to 1.48; p = 0.011). PPI was associated with lesser improvement in LVEF over time (p = 0.051 for changes in LVEF between groups), particularly in patients with reduced LVEF before TAVR (p = 0.005 for changes in LVEF between groups)., Conclusions: The need for PPI post-TAVR was frequent and associated with an increased risk of heart failure rehospitalization and lack of LVEF improvement, but not mortality, after a median follow-up of 4 years. Most patients with new PPI post-TAVR exhibited some degree of pacing activity at follow-up., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We compared the outcome of anaemic patients undergoing transcatheter (TAVI) and surgical aortic valve replacement (SAVR) for severe aortic valve stenosis., Methods: Anaemic patients (haemoglobin <13.0 g/dL in men and <12.0 g/dL in women) undergoing TAVI and SAVR from the OBSERVANT study were the subjects of this analysis., Results: Preoperative anaemia was an independent predictor of 3-year mortality after either TAVI (HR 1.37, 95% CI 1.12-1.68) and SAVR (HR 1.63, 95% CI 1.37-1.99). Propensity score matching resulted in 302 pairs with similar characteristics. Patients undergoing SAVR had similar 30-d mortality (3.6% versus 3.3%, p = .81) and stroke (1.3% versus 2.0%, p = .53) compared with TAVI. The rates of pacemaker implantation (18.6% versus 3.0%, p < .001), major vascular damage (5.7% versus 0.4%, p < .001) and mild-to-severe paravalvular regurgitation (47.4% versus 9.3%, p < .001) were higher after TAVI, whereas acute kidney injury (50.7% versus 27.9%, p < .001) and blood transfusion (70.0% versus 38.6%, p < .001) were more frequent after SAVR. At 3-year, survival was 74.0% after SAVR and 66.3% after TAVI, respectively (p = .065), and freedom from MACCE was 67.6% after SAVR and 58.7% after TAVI, respectively (p = .049)., Conclusions: These results suggest that TAVI is not superior to SAVR in patients with anaemia.

Aims: Transcatheter aortic valve implantation for a failing surgical bioprosthesis (TAV-in-SAV) has become an alternative for patients at high risk for redo surgical aortic valve replacement (redo-SAVR). Comparisons between these approaches are non-existent. This study aimed to compare clinical and echocardiographic outcomes of patients undergoing TAV-in-SAV versus redo-SAVR after accounting for baseline differences by propensity score matching., Methods and Results: Patients from seven centres in Europe and Canada who had undergone either TAV-in-SAV (n=79) or redo-SAVR (n=126) were identified. Significant independent predictors used for propensity scoring were age, NYHA functional class, number of prior cardiac surgeries, urgent procedure, pulmonary hypertension, and COPD grade. Using a calliper range of ±0.05, a total of 78 well-matched patient pairs were found. All-cause mortality was similar between groups at 30 days (6.4% redo-SAVR vs. 3.9% TAV-in-SAV; p=0.49) and one year (13.1% redo-SAVR vs. 12.3% TAV-in-SAV; p=0.80). Both groups also showed similar incidences of stroke (0% redo-SAVR vs. 1.3% TAV-in-SAV; p=1.0) and new pacemaker implantation (10.3% redo-SAVR vs. 10.3% TAV-in-SAV; p=1.0). The incidence of acute kidney injury requiring dialysis was numerically lower in the TAV-in-SAV group (11.5% redo-SAVR vs. 3.8% TAV-in-SAV; p=0.13). The TAV-in-SAV group had a significantly shorter median total hospital stay (12 days redo-SAVR vs. 9 days TAV-in-SAV; p=0.001)., Conclusions: Patients with aortic bioprosthesis failure treated with either redo-SAVR or TAV-in-SAV have similar 30-day and one-year clinical outcomes.

Background: Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting., Objective: To report clinical and echocardiographic 3-year results from the ADVANCE study., Methods: ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years., Results: Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm 2 from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration., Conclusions: Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality., Trial Registration: ClinicalTrials.gov, NCT01074658.

In the last 15 years, transcatheter aortic valve implantation (TAVI) technology has met with rapid uptake, with >350,000 procedures performed in >70 countries. Over the same period, this technique has evolved from a challenging intervention to a standardised, simple, and streamlined procedure. The purpose of this review article is to provide an overview on the rapidly changing field of TAVI therapy, exploring past achievements, current issues and future perspectives. The discussion has been subdivided into three sections: 1) the evolution of clinical and anatomical indications for TAVI, 2) the description of procedural advances and complication rate trends over time, and 3) the progressive adoption of a minimalist approach.

Objectives: This study sought to assess the influence of baseline right bundle branch block (RBBB) on all-cause and cardiovascular mortality as well as sudden cardiac death (SCD) among patients undergoing transcatheter aortic valve replacement (TAVR)., Background: Few data exist regarding the late clinical impact of pre-existing RBBB in TAVR recipients., Methods: A total of 3,527 patients (mean age 82 ± 8 years, 50.1% men) were evaluated according to the presence of RBBB on baseline electrocardiography. Intraventricular conduction abnormalities were classified according to the American Heart Association, American College of Cardiology Foundation, and Heart Rhythm Society recommendations for standardization and interpretation of the electrocardiogram. TAVR complications and causes of death were defined according to Valve Academic Research Consortium 2 definitions., Results: RBBB was present on baseline electrocardiography in 362 patients (10.3%) and associated with higher 30-day rates of permanent pacemaker implantation (PPI) (40.1% vs. 13.5%; p < 0.001) and death (10.2% vs. 6.9%; p = 0.024). At a mean follow-up of 20 ± 18 months, pre-existing RBBB was independently associated with all-cause mortality (hazard ratio [HR]: 1.31; 95% confidence interval [CI]: 1.06 to 1.63; p = 0.014) and cardiovascular mortality (HR: 1.45; 95% CI: 1.11 to 1.89; p = 0.006) but not with SCD (HR: 0.71; 95% CI: 0.22 to 2.32; p = 0.57). Patients with pre-existing RBBB and without PPI at discharge from the index hospitalization had the highest 2-year risk for cardiovascular death (27.8%; 95% CI: 20.9% to 36.1%; log-rank p = 0.007). In a subanalysis of 1,245 patients without PPI at discharge from the index hospitalization and with complete follow-up regarding the need for PPI, pre-existing RBBB was independently associated with the composite of SCD and PPI (HR: 2.68; 95% CI: 1.16 to 6.17; p = 0.023)., Conclusions: Pre-existing RBBB was found in 10% of TAVR recipients and was associated with poorer clinical outcomes. Patients with baseline RBBB without permanent pacemakers at hospital discharge may be at especially high risk for high-degree atrioventricular block and/or SCD during follow-up. Future studies should evaluate strategies aimed at the early detection of patients at risk for late development of high-degree atrioventricular block., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS)., Objectives: This study sought to compare the procedural and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry., Methods: Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria., Results: Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28)., Conclusions: Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes., Methods and Results: We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate-severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9-2.05, p=0.012 for mild PVL, HR 1.36, CI 95% 0.9-2.05, p<0.001 for PVL≥moderate and OR 1.04, p=0.97 respectively). Patients with moderate-severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m 2 ) showed better survival than those without dilatation (HR 8.63, p=0.001)., Conclusions: In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Introduction: Little is known about the early and late performance of the 31mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31mm CRS with other valve sizes., Methods: Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31mm and other valve sizes (i.e., 23, 26, and 29mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed., Results: In total, 2069 patients (n=169 [8%] in the 31mm group and n=1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p=0.030) and device-success (88.5% vs. 97.1%, p=0.016), longer procedural time (120 [80-180] min. vs. 90 [60-120] min., p<0.001), and higher rates of implantation of a second valve (10.6% vs. 2.9%, respectively, p=0.027). The rates of permanent pacemaker implantation in the 31mm group were higher but not statistically different from other valve sizes (41.7% vs. 30.9%, respectively, p=0.149). Significant improvement, without between-group differences, was observed in NYHA functional class. Cardiovascular death was lower in the 31mm valve group through 2-years (3.8% vs. 13.5%, respectively, p=0.014)., Conclusions: The acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Rationale: The impact of transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR) on cognitive status and quality of life in high-risk patients has been incompletely investigated., Methods: We conducted a prospective, multicenter study including all patients treated with TAVI and high-risk patients undergoing AVR (age ≥80 years or logistic EuroSCORE ≥15%) at participating centers. Multidimensional geriatric evaluation including Mini Mental State Examination (MMSE), EuroQol 5D (EQ5D) and Minnesota Living With Heart Failure Questionnaire (MLHFQ) were performed at baseline and at 3- and 12-month follow-up., Results: A total of 518 patients (151 AVR and 367 TAVI) were enrolled in 10 Italian institutions. Patients receiving AVR were older (82.7 ± 2.4 years), with a lower logistic EuroSCORE (12.5 ± 7.1%) as compared with TAVI patients (81.5 ± 6.2 years and 19.6 ± 14.0%, respectively, p=0.001 and p<0.001). Overall, 35.5% of patients showed some degree of cognitive impairment at baseline, with no differences between groups. No significant changes in the cognitive status were observed between baseline and follow-up and between groups at any time point. TAVI patients had a lower quality of life at baseline as compared with AVR patients. Generic and heart failure-related quality of life improved significantly after either procedure., Conclusions: In high-risk patients, both TAVI and AVR are associated with a significant improvement of quality of life up to 1 year without a detrimental effect on cognitive function.

Objectives: This study sought to evaluate transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) aortic stenosis (AS), with a particular emphasis on TAVR-directed bicuspid aortic valve imaging (BAVi) of morphological classification., Background: TAVR has been used to treat BAV-AS but with heterogeneous outcomes and uncertainty regarding the relevance of morphology., Methods: In 14 centers in the United States, Canada, Europe, and Asia, 130 BAV-AS patients underwent TAVR. Baseline cardiac computed tomography (CT) was analyzed by a dedicated Corelab. Outcomes were assessed in line with Valve Academic Research Consortium criteria., Results: Bicommissural BAV (vs. tricommissural) accounted for 68.9% of those treated in North America, 88.9% in Europe, and 95.5% in Asia (p = 0.003). For bicommissural bicuspids, non-raphe type (vs. raphe type) BAV accounted for 11.9% of those treated in North America, 9.4% in Europe, and 61.9% in Asia (p < 0.001). Overall rates of 30-day mortality (3.8%) and cerebrovascular events (3.2%) were favorable and similar among anatomical subsets. The rate of new permanent pacemaker insertion was high (26.2%) and similar between balloon-expandable (BE) and self-expanding (SE) designs (BE: 25.5% vs. SE: 26.9%; p = 0.83); there was a trend to greater permanent pacemaker insertion in BE TAVR in the presence of coronary cusp fusion BAV morphology. Paravalvular aortic regurgitation (PAR) ≥ moderate was 18.1% overall but lower at 11.5% in those with pre-procedural CT. In the absence of pre-procedural CT, there was an excess of PAR in BE TAVR that was not the case in those with a pre-procedural CT; SE TAVR required more post-dilation. Predictors of PAR included intercommissural distance for bicommissural bicuspids (odd ratio [OR]: 1.37; 95% confidence interval [CI]: 1.02 to 1.84; p = 0.036) and lack of a baseline CT for annular measurement (OR: 3.03; 95% CI: 1.20 to 7.69; p = 0.018)., Conclusions: In this multicenter study, TAVR achieved favorable outcomes in patients with pre-procedural CT, with the exception of high permanent pacemaker rates for all devices and shapes., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

There is a growing body of evidence demonstrating the durability of current transcatheter aortic valve implantation (TAVI) devices up to 5 years. However, it is well known that transcatheter aortic valves can degenerate in a manner similar to surgical bioprostheses. In this review we briefly discuss the modes of failure of trans-catheter aortic valves and their potential management.

Background: Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices., Objectives: This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices., Methods: The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015., Results: Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99)., Conclusions: The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valves can degenerate in a manner similar to surgical bioprostheses., Methods and Results: Clinical and echocardiographic outcomes of patients who underwent redo transcatheter aortic valve replacement (TAVR) procedures >2 weeks post procedure were collected from 14 centers. Among 13 876 patients, 50 (0.4%) underwent redo TAVR procedure at participating centers. Indications for redo TAVR were moderate-severe prosthetic aortic valve stenosis (n=10, 21.7%), moderate-severe central prosthetic aortic valve regurgitation (n=13, 28.3%), and moderate-severe paraprosthetic aortic valve regurgitation (n=25, 50.0%). The index TAVR was most commonly a Medtronic CoreValve (N=38, 76.0%), followed by Edwards SAPIEN-type valves (n=12, 24.0%) and Portico (n=1, 2.0%). The redo TAVR device was most commonly a CoreValve/Evolut R (n=29, 58.0%), followed by a SAPIEN-type valve (n=20,40.0%) or a Boston Lotus valve (n=1, 2.0%). In 40 patients (80.0%), redo TAVR was performed using the identical device type or that of the succeeding generation. Valve performance was uniformly good after redo TAVR (mean transvalvular gradient post redo TAVR: 12.5±6.1 mm Hg). At hospital discharge, all patients remained alive, with 1 nondisabling stroke (2.0%) and 1 life-threatening bleed (2.0%). Permanent pacemaker implantation was required in 3 out of 35 patients without a prior pacemaker (8.6%). Late survival was 85.1% at a median follow-up of 1589 days (range: 31-3775) after index TAVR and 635 days (range: 8-2460) after redo TAVR., Conclusions: Redo TAVR for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter aortic valve prosthesis failure seems to be safe, and it is associated with favorable acute and midterm clinical and echocardiographic outcomes., (© 2016 American Heart Association, Inc.)

Background: Severe pulmonary hypertension (PH) is considered to negatively affect the outcome after transcatheter aortic valve replacement. However, a clear understanding of the pattern, evolution, and clinical impact of different grades of PH in this setting is lacking., Methods and Results: A total of 990 consecutive patients were enrolled in 6 high-volume centers and analyzed as follows: group 1, systolic pulmonary artery pressure (sPAP) <40 mm Hg (346 patients; 35%); group 2, sPAP 40 to 60 mm Hg (426 patients; 43%); and group 3, sPAP >60 mm Hg (218 patients; 22%). At 1 month, mortality rate did not differ across the groups. When compared with groups 1 and 2, patients in group 3 had a higher-rate of New York Heart Association 3 to 4 (26% versus 12% and 10%), and a higher-rate of hospitalization for heart failure (7% versus 3% and 3%). At 1 year, when compared with patients in group 1, patients in group 2 and 3 had both a higher overall mortality (hazard ratio [HR], 1.5 [1.3-3.2]; P=0.01 and HR, 2.3 [1.8-2.8]; P=0.001) and a higher cardiac mortality (HR, 1.3 [1.1-2.1]; P=0.01 and HR, 1.7 [1.3-2.5]; P=0.002). After 1 month, the sPAP decreased ≥15 mm Hg in 32% and 35% of the patients in groups 2 and 3. Baseline sPAP >60 mm Hg (HR, 1.6 [1.1-2.3]; P=0.03) and, in a larger extent, a persistent severe PH after 1 month (HR, 2.4 [1.5-2.8]; P=0.004), independently predicted 1-year mortality, whereas the 1-month reduction of the sPAP did not., Conclusions: The persistence of severe PH after transcatheter aortic valve replacement is a stronger predictor of 1-year mortality than baseline severe PH. The early reduction of sPAP is not associated with a reduced mortality. The benefit of transcatheter aortic valve replacement in terms of quality of life is substantial in patients with and without a reduction of sPAP at early follow-up., (© 2016 American Heart Association, Inc.)

Background: The proven efficacy of transcatheter aortic valve implantation (TAVI) in high-risk patients is leading to the expansion of its indications toward lower-risk patients. However, this shift is not supported by meaningful evidence of its benefit over surgical aortic valve replacement (SAVR). This analysis aims to describe outcomes of TAVI versus SAVR in low-risk patients., Methods and Results: We compared the outcome after TAVI and SAVR of low-risk patients (European System for Cardiac Operative Risk Evaluation II [EuroSCORE II] <4%) included in the Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study. The primary outcome was 3-year survival. Secondary outcomes were early events and major adverse cardiac and cerebrovascular events at 3 years. Propensity score matching resulted in 355 pairs of patients with similar baseline characteristics. Thirty-day survival was 97.1% after SAVR and 97.4% after TAVI (P=0.82). Cardiac tamponade, permanent pacemaker implantation, major vascular damage, and moderate-to-severe paravalvular regurgitation were significantly more frequent after TAVI compared with SAVR. Stroke rates were equal in the study groups. SAVR was associated with higher risk of cardiogenic shock, severe bleeding, and acute kidney injury. At 3 years, survival was 83.4% after SAVR and 72.0% after TAVI (P=0.0015), whereas freedom from major adverse cardiac and cerebrovascular events was 80.9% after SAVR and 67.3% after TAVI (P<0.001)., Conclusions: In patients with low operative risk, significantly better 3-year survival and freedom from major adverse cardiac and cerebrovascular events were observed after SAVR compared with TAVI. Further studies on new-generation valve prostheses are necessary before expanding indications of TAVI toward lower-risk patients., (© 2016 American Heart Association, Inc.)

Objectives: This study evaluated the results of transcatheter aortic valve replacement (TAVR) in bicuspid aortic stenosis (AS) using a new-generation TAVR device., Background: A bicuspid AS is often considered a relative contraindication to TAVR. Although initial reports have demonstrated feasibility using early-generation devices, outcomes have not matched those seen with tricuspid AS. Paravalvular aortic regurgitation (AR) has been particularly problematic., Methods: We collected baseline characteristics, procedural data, and 30-day clinical follow-up findings from 8 centers in Europe and Canada that had performed TAVR in bicuspid AS using the SAPIEN 3 valve., Results: 51 patients underwent TAVR using the SAPIEN 3 valve. Patient mean age was 76.2 ± 9.3 years and the Society of Thoracic Surgeons predicted risk of mortality scores were 5.2 ± 3.7%. Bicuspid valve types were: type 0, 11.8%; type 1, 82.3%; and type 2, 1.9%. There were no cases of valve embolization or need for a second valve. Post-dilation was performed in 7.8%. The mean aortic gradient decreased from 49.4 ± 16.0 mm Hg to 11.2 ± 4.7 mm Hg. Post-implantation AR was none/trivial in 63% and mild in 37%. There were no cases of moderate or severe AR. At 30-day follow-up, there were 2 deaths (3.9%), 2 major vascular complications, and 12 patients (23.5%) required pacemaker implantation., Conclusions: TAVR in bicuspid AS using a new-generation device was feasible and effective with favorable valve performance and no cases of moderate or severe AR., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score >7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium-1 definitions. A total of 996 patients were implanted: STS ≤7% (n = 697, median STS 4.3%, interquartile range 3.1% to 5.4%) and STS >7% (n = 298, median STS 9.7%, interquartile range 8.0% to 12.4%). At 3 years, the STS ≤7% group had lower rates of all-cause mortality (28.6 vs 45.9, p <0.01) and cardiovascular mortality (19.0 vs 30.2, p <0.01) than the STS >7% group. No differences were observed in cerebrovascular accidents, vascular complications, bleeding, or myocardial infarction. In patients with STS ≤7%, mortality at 3 years was higher in those with moderate or severe aortic regurgitation (AR) at discharge than in those with mild or less AR (39.9% vs 22.9%; hazard ratio 1.98; 95% confidence interval 1.37 to 2.86; p <0.01). Conversely, the severity of AR at discharge did not affect 3-year mortality in patients with STS >7% (42.9% vs 44.6%, moderate/severe vs mild/less; hazard ratio 1.04; 95% confidence interval, 0.62 to 1.75; p = 0.861; p for interaction = 0.047). In conclusion, patients with STS ≤7% had lower rates of all-cause and cardiovascular mortality at 3 years after transcatheter aortic valve implantation. Complication rates were low and stable in both groups, demonstrating the safety of this procedure for patients at various levels of surgical risk., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The aim of this study was to compare the immediate outcome of patients undergoing transcatheter (TAVI) versus surgical aortic valve replacement with the sutureless Perceval bioprosthesis (SU-AVR). This is a retrospective multicenter analysis of 773 patients who underwent either TAVI (394 patients, mean age, 80.8 ± 5.5 years, mean EuroSCORE II 5.6 ± 4.9 %) or SU-AVR (379 patients, 77.4 ± 5.4 years, mean EuroSCORE II 4.0 ± 3.9 %) with or without concomitant myocardial revascularization. Data on SU-AVRs were provided by six European institutions (Belgium, Finland, Germany, Italy and Sweden) and data on TAVIs were provided by a single institution (Catania, Italy). In-hospital mortality was 2.6 % after SU-AVR and 5.3 % after TAVI (p = 0.057). TAVI was associated with a significantly high rate of mild (44.0 vs. 2.1 %) and moderate-severe paravalvular regurgitation (14.1 vs. 0.3 %, p < 0.0001) as well as the need for permanent pacemaker implantation (17.3 vs. 9.8 %, p = 0.003) compared with SU-AVR. The analysis of patients within the 25th and 75th percentiles interval of EuroSCORE II, i.e., 2.1-5.8 %, confirmed the findings of the overall series. One-to-one propensity score-matched analysis resulted in 144 pairs with similar baseline characteristics and operative risk. Among these matched pairs, in-hospital mortality (6.9 vs. 1.4 %, p = 0.035) was significantly higher after TAVI. SU-AVR with the Perceval prosthesis in intermediate-risk patients is associated with excellent immediate survival and is a valid alternative to TAVI in these patients.

The current transcatheter aortic valve implantation (TAVI) devices have been designed to fit Caucasian and Latin American aortic root anatomies. We evaluated the racial differences in aortic root anatomy and calcium distribution in patients with aortic stenosis who underwent TAVI. We conducted a multicenter study of 4 centers in Asia and Europe, which includes consecutive patients who underwent TAVI with preprocedural multidetector computed tomography. Quantitative assessment of aortic root dimensions, calcium volume for leaflet, and left ventricular outflow tract were retrospectively performed in a centralized core laboratory. A total of 308 patients (Asian group, n = 202; Caucasian group, n = 106) were analyzed. Compared to Caucasian group, Asian group had smaller annulus area (406.3 ± 69.8 vs 430.0 ± 76.8 mm(2); p = 0.007) and left coronary cusp diameter (30.2 ± 3.2 vs 31.1 ± 3.4 mm; p = 0.02) and lower height of left coronary artery ostia (12.0 ± 2.5 vs 13.4 ± 3.4 mm; p <0.001). Of baseline anatomic characteristics, body height showed the highest correlation with annulus area (Pearson correlation r = 0.64; p <0.001). Co-existence of lower height of left coronary artery ostia (<12 mm) and small diameter of left coronary cusp (<30 mm) were more frequent in Asian group compared with Caucasian group (35.6% vs 20.8%; p = 0.02). In contrast, there were no differences in calcium volumes of leaflet (367.2 ± 322.5 vs 359.1 ± 325.7 mm(3); p = 0.84) and left ventricular outflow tract (8.9 ± 23.4 vs 10.1 ± 23.8 mm(3); p = 0.66) between 2 groups. In conclusion, judicious consideration will be required to perform TAVI for short patients with lower height of left coronary artery ostia and small sinus of Valsalva., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR)., Background: TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored., Methods: The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure., Results: The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days., Conclusions: Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to compare outcomes with the use of two haemostasis strategies after transfemoral transcatheter aortic valve implantation (TAVI) - one Prostar® vs. two ProGlide® devices (Abbott Vascular Inc., Santa Clara, CA, USA)., Methods and Results: This was a retrospective study enrolling consecutive patients undergoing fully percutaneous transfemoral TAVI in our centre (Ferrarotto Hospital, Catania, Italy) from January 2012 to October 2014. All patients were dichotomised according to the vascular closure device (VCD) used for common femoral artery haemostasis (Prostar vs. ProGlide). All outcomes were defined according to VARC-2 criteria. The study population encompassed a total of 278 patients. Of these, 153 (55.1%) underwent TAVI using the Prostar, and 125 (44.9%) using two ProGlide devices. Vascular complications occurred in 48 patients (17.3%), being more frequent in the ProGlide group (11.8% vs. 24.0%, p=0.007). Patients who had TAVI using the ProGlide were also more likely to have a higher rate of percutaneous closure device failure (4.6% vs. 12.8%, p=0.013). Percutaneous peripheral intervention was performed in 13.7% and 28.0% of Prostar and ProGlide cases, respectively (p=0.003)., Conclusions: Patients undergoing transfemoral TAVI had significantly lower rates of vascular complications and percutaneous closure device failures when the Prostar was used compared with two ProGlide devices.

Background: A detailed assessment of calcium within the aortic root may provide important additional information regarding the risk of aortic root injury during transcatheter heart valve replacement (TAVR)., Objective: We sought to delineate the effect of calcium volume and distribution on aortic root injury during TAVR., Methods: Thirty-three patients experiencing aortic root injury during TAVR with a balloon-expandable valve were compared with a control group of 153 consecutive TAVR patients without aortic root injury (as assessed by post-TAVR multidetector CT). Using commercial software to analyze contrast-enhanced pre-TAVR CT scans, calcium volume was determined in 3 regions: (1) the overall left ventricular outflow tract (LVOT), extending 10 mm down from the aortic annulus plane; (2) the upper LVOT, extending 2 mm down from the annulus plane; and (3) the aortic valve region., Results: Calcium volumes in the upper LVOT (median, 29 vs 0 mm(3); P < .0001) and overall LVOT (median, 74 vs 3 mm(3); P = .0001) were higher in patients who experienced aortic root injury compared with the control group. Calcium in the aortic valve region did not differ between groups. Upper LVOT calcium volume was more predictive of aortic root injury than overall LVOT calcium volume (area under receiver operating curve [AUC], 0.78; 95% confidence interval, 0.69-0.86 vs AUC, 0.71; 95% confidence interval, 0.62-0.82; P = .010). Upper LVOT calcium below the noncoronary cusp was significantly more predictive of aortic root injury compared to calcium underneath the right coronary cusp or the left coronary cusp (AUC, 0.81 vs 0.68 vs 0.64). Prosthesis oversizing >20% (likelihood ratio test, P = .028) and redilatation (likelihood ratio test, P = .015) improved prediction of aortic root injury by upper LVOT calcium volume., Conclusion: Calcification of the LVOT, especially in the upper LVOT, located below the noncoronary cusp and extending from the annular region, is predictive of aortic root injury during TAVR with a balloon-expandable valve., (Copyright © 2015 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objective: To analyze the association between computed-tomography-derived degrees of device oversizing and clinical outcomes during transcatheter aortic valve replacement (TAVR)., Background: Previous reports suggest that different devices reach optimal results with different degrees of device oversizing. Therefore, similar sized devices of different types (SAPIEN XT and CoreValve) may be favored in different annular ranges and a case considered borderline between two sizes of a specific device might be within a favorable range of another., Methods and Results: A multicenter registry of 615 consecutive transfemoral TAVR procedures using either SAPIEN XT or CoreValve was analyzed. A first group of 190 patients had annular sizes for which only moderate oversizing degree was feasible (5-20% by area or 2.5-9.5% by perimeter). A second group included 178 patients that had annulus size for which only large oversizing degree was feasible (20.1-35% by area or 9.6-16.2% by perimeter). In the "only large oversizing feasible group" there were more annular rupture events in patients treated by SAPIEN XT valve as compared to those treated by CoreValve (3.4% vs. 0%, P = 0.04). In the "only moderate oversizing feasible group", those treated by CoreValve had more post balloon dilatation and 30-day major stroke in comparison with those treated by SAPIEN XT (16.1% vs. 7.7%, P = 0.04 and 8% vs. 1.3%, P = 0.02, respectively)., Conclusions: Optimal clinical performance of CoreValve and SAPIEN XT appears to be reached with different degrees of oversizing. Certain annular sizes that allow for only moderate or large oversizing, but not both, appear to benefit from a device specific approach., (© 2015 Wiley Periodicals, Inc.)

Background: There has been conflicting clinical evidence as to the influence of female sex on outcomes after transcatheter aortic valve replacement., Objectives: The aim of this study was to evaluate the impact of sex on early and late mortality and safety end points after transcatheter aortic valve replacement using a collaborative meta-analysis of patient-level data., Methods: From the MEDLINE, Embase, and the Cochrane Library databases, data were obtained from 5 studies, and a database containing individual patient-level time-to-event data was generated from the registry of each selected study. The primary outcome of interest was all-cause mortality. The safety end point was the combined 30-day safety end points of major vascular complications, bleeding events, and stroke, as defined by the Valve Academic Research Consortium when available., Results: Five studies and their ongoing registry data, comprising 11,310 patients, were included. Women constituted 48.6% of the cohort and had fewer comorbidities than men. Women had a higher rate of major vascular complications (6.3% vs. 3.4%; p < 0.001), major bleeding events (10.5% vs. 8.5%; p = 0.003), and stroke (4.4% vs. 3.6%; p = 0.029) but a lower rate of significant aortic incompetence (grade ≥2; 19.4% vs. 24.5%; p < 0.001). There were no differences in procedural and 30-day mortality between women and men (2.6 % vs. 2.2% [p = 0.24] and 6.5% vs. 6.5% [p = 0.93], respectively), but female sex was independently associated with improved survival at median follow-up of 387 days (interquartile range: 192 to 730 days) from the index procedure (adjusted hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p = 0.001)., Conclusions: Although women experience more bleeding events, as well as vascular and stroke complications, female sex is an independent predictor of late survival after transcatheter aortic valve replacement. This should be taken into account during patient selection for this procedure., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with symptomatic aortic stenosis without open-heart surgery; however, the benefits are mitigated by the potential for neurological events., Objectives: This study sought to determine the timing and causes of clinically relevant neurological events after self-expandable TAVR., Methods: We enrolled 1,015 patients, of whom 996 underwent TAVR with a self-expandable system at 44 TAVR-experienced centers in Europe, Colombia, and Israel. Neurological events were evaluated for 3 distinct time periods: periprocedural (0 to 1 days post TAVR); early (2 to 30 days); and late (31 to 730 days). In this real-world study, neurological events were first referred to the site neurologist and then reviewed by an independent neurologist., Results: The overall stroke rate was 1.4% through the first day post-procedure, 3.0% at 30 days, and 5.6% at 2 years. There were no significant predictors of periprocedural stroke or stroke/transient ischemic attack (TIA) combined. Significant predictors of early stroke were acute kidney injury (p = 0.03), major vascular complication (p = 0.04), and female sex (p = 0.04). For stroke/TIA combined, prior atrial fibrillation (p = 0.03) and major vascular complication (p = 0.009) were predictive. Coronary artery bypass graft surgery was the only significant predictor of late stroke (p = 0.007) or late stroke/TIA (p = 0.06)., Conclusions: Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically relevant neurological events differed on the basis of the timing after TAVR. (CoreValve Advance International Post Market Study; NCT01074658)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)