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Background: The ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves., Methods: A retrospective analysis of the Israeli TAVR registry between the years 2014-2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics., Results: Following exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3-37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3-31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL., Conclusions: In this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL., Competing Interests: Declaration of competing interest Prof. Ariel Finkelstein reports a relationship with Medtronic Inc. that includes: consulting or advisory. Prof. Ariel Finkelstein reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Prof. Amir Halkin reports a relationship with Abbott Laboratories that includes: consulting or advisory. Prof. Amir Halkin reports a relationship with Boston Scientific Corp that includes: consulting or advisory. Other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Eccentricity of coronary ostial positions in relation to the aortic valve cusp may influence the target laceration location in BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Coronary Artery obstruction). Eccentricity of the coronary ostia in relation to coronary cusps of native and valve-in-valve transcatheter aortic valve replacement (TAVR) was not well described before., Methods: A total of 121 pre-TAVR patients' CT data (72 native valves TAVR and 49 bioprosthetic surgical valves TAVR) was included and coronary ostial eccentricity angles were measured and compared. Coronary ostial angles were measured between mid-cusp line to coronary ostium in CT perpendicular images., Results: In the overall cohort, the right coronary artery (RCA) had an eccentric origin in the majority of cases, favoring the commissure between the right and the non coronary cusp (17.0°, IQR; 10-25). On the other hand, the left coronary artery (LCA) originated most commonly near center of the cusp position (0°, IQR; -8 -7.5) In comparison of native and bioprosthetic valves, RCA ostial angles were more eccentric in native valves (19.0°, IQR; 12-26) than in bioprosthetic valves (14.0°, IQR; 3-20) (p = 0.004). Whereas, LCA ostial angle has no significant differences between native valves (-2.0°, IQR;-7.75-5.75) and bioprosthetic valves (1°, IQR;-8-13), (p = 0.6)., Conclusion: RCA ostia often have an eccentric origin towards the non-coronary cusp, especially in native aortic valves, while LCA ostia commonly originate near the center of the cusp. This finding may contribute to better performance of BASILICA procedures., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr HC Wijeysundera received research funding from Medtronic Inc and Edwards Lifesciences. Dr.JM McCabe is a consultant to Edwards LifeSciences, Boston Scientific. Dr N Piazza is a consultant and proctor for Medtronic and Microport. D Dvir, is a consultant to Edwards Lifesciences, Medtronic, Gore, Jena, Abbott. All other authors have no potential conflicts of interest to disclose with regard to any part of the data or results in this report., (Copyright © 2020 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objectives: Transcatheter aortic valve replacement (TAVR) is established therapy for severe aortic stenosis patients with intermediate-, high- and prohibitive-risk for surgery. A significant challenge when expanding TAVR to low-risk and younger patients is the unknown long-term durability. High leaflet stresses have been associated with surgical bioprosthetic valve degeneration. In this study, we examined the impact of changes in valve design across 3 generations of same-sized TAVR devices on stent and leaflet stresses., Methods: The 26-mm Edwards SAPIEN, 23, 26 and 29 mm SAPIEN XT (XT) and 26 mm SAPIEN 3 (S3) (n = 1 each) underwent micro-computed tomography (micro-CT) scanning. Dynamic finite element computational simulations of 23-26 mm SAPIEN, 23-29 mm XT and 23-29 mm S3 were performed with physiological loading and micro-CT or scaled geometries., Results: Peak stresses were concentrated in the commissure area and along the bottom of the suture, representing areas most likely to develop structural valve degeneration across TAVR generations. Latest-generation S3 showed greatest 99th percentile principal stress on commissural leaflets for 26 and 29 mm, and increased stresses over XT for 23 mm. Percentage of higher stress areas within the leaflets steadily increased across generations, 3.8%, 3.9% and 5.7%, respectively, for 26 mm SAPIEN, XT and S3 with similar trend for 29-mm valves., Conclusions: Using computational simulations based on high-fidelity modelling of balloon-expandable TAVRs, our study demonstrated that maximum stress areas existed in similar leaflet locations across SAPIEN generations, while the latest model S3 had the highest magnitude for both 26- and 29-mm valves. S3 also had the largest area of higher stresses than other generations, which would be prone to degeneration. Our study coupled with future long-term clinical outcomes >10 years will provide insight on biomechanics of TAVR degeneration., (Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery 2020. This work is written by US Government employees and is in the public domain in the US.)

Objectives: The aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO)., Background: CAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication., Methods: In the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR., Results: To date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p < 0.01), cardiogenic shock (52.0% vs. 2.9%; p < 0.01), and resuscitation (44.0% vs. 2.9%; p < 0.01) all occurred more frequently in patients with established CAO compared with those with impending CAO. The absence of upfront coronary protection was the sole independent risk factor for the combined endpoint of death, cardiogenic shock, or myocardial infarction. During a median follow-up time of 612 days (interquartile range: 405 to 842 days), 2 cases of stent failure were reported (1 in-stent restenosis, 1 possible late stent thrombosis) after 157 and 374 days., Conclusions: Chimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: A combination of evolving 3D printing technologies, new 3D printable materials, and multi-disciplinary collaborations have made 3D printing applications for transcatheter aortic valve replacement (TAVR) a promising tool to promote innovation, increase procedural success, and provide a compelling educational tool. This review synthesizes the knowledge via publications and our group's experience in this area that exemplify uses of 3D printing for TAVR., Recent Findings: Patient-specific 3D-printed models have been used for TAVR pre-procedural device sizing, benchtop prediction of procedural complications, planning for valve-in-valve and bicuspid aortic valve procedures, and more. Recent publications also demonstrate how 3D printing can be used to test assumptions about why certain complications occur during THV implantation. Finally, new materials and combinations of existing materials are starting to bridge the large divide between current 3D material and cardiac tissue properties. Several studies have demonstrated the utility of 3D printing in understanding challenges of TAVR. Innovative approaches to benchtop testing and multi-material printing have brought us closer to being able to predict how a THV will interact with a specific patient's aortic anatomy. This work to date is likely to open the door for advancements in other areas of structural heart disease, such as interventions involving the mitral valve, tricuspid valve, and left atrial appendage.

Objectives: Time trends in surgical valve selection have not been explored in detail in the era of transcatheter aortic valve replacement (TAVR) in nationally representative data. Herein, we explore valve selection trends in the TAVR era using the Society of Thoracic Surgeons Adult Cardiac Surgery Database., Methods: Isolated first-time biological or mechanical aortic valve replacements (AVR) from 2004 to 2016 in the Society of Thoracic Surgeons Adult Cardiac Surgery Database were included. Patient characteristics were examined in the pre-TAVR era (2004-2007) and the post-TAVR era (2008-2016) using the year 2007 as the cut-point. Using a piece-wise regression analysis to model the relationship between time and type of valve used, a change-point analysis was performed to empirically determine the time of change in practice, both overall and in age-specific subgroups (≤60 years and >60 years)., Results: In total, 214,390 patients underwent isolated primary mechanical or biological AVR from 2004 to 2016. The patients' mean age increased slightly between the 2 eras (67.1 vs 68.6 years, P < .001), whereas the proportion of mechanical AVRs decreased (24.8% vs 12.2%, P < .001). Piece-wise regression demonstrated that the proportion of mechanical valves decreased over time. An empirically estimated slope change-point was found after the first quarter 2010; from 2004 to 2009, the overall proportion of mechanical valves was decreasing quickly (-2.81%/year, 95% confidence interval [95% CI], -3.03% to -2.60%), compared with 2010 to 2016. The early decline was steeper for younger patients (-4.21%/year, 95% CI, -4.74 to -3.69) compared with older patients (-1.44%/year, 95% CI -1.64 to -1.23)., Conclusions: Use of mechanical AVR declined significantly from 2004 to 2016 and was decreasing before the introduction or the approval of TAVR in the United States., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) can result in high residual gradients that are associated with increased mortality. Bioprosthetic valve fracture (BVF) has been shown to improve residual gradients following VIV TAVR; however, factors influencing the results of BVF have not been studied., Methods: BVF was performed in 75 patients at 21 centers. Hierarchical multiple linear regression was performed to identify variables that were associated with lower final transvalvular gradient., Results: Surgical valves with a median true internal diameter of 18.5 mm (interquartile range, 17.0-20.5 mm) were treated with VIV TAVR in conjunction with BVF using balloon-expandable (n = 43) or self-expanding (n = 32) transcatheter heart valves with a median size of 23 mm (interquartile range, 23-23 mm). There were no aortic root disruptions, coronary occlusions, or new pacemakers; in-hospital or 30-day mortality was 2.6% (2 out of 75). Final mean transvalvular gradient was 9.2 ± 6.3 mm Hg, but was significantly lower when BVF was performed after VIV TAVR compared with BVF first (8.1 ± 4.8 mm Hg vs 16.9 ± 10.1 mm Hg; P < .001). After adjusting for timing of BVF (ie, before or after VIV TAVR), transcatheter heart valve size/type, surgical valve mode of failure, true internal diameter, and baseline gradient and BVF balloon size, performing BVF after VIV TAVR (P < .001) and using a larger BVF balloon (P = .038) were the only independent predictors of lower final mean gradient., Conclusions: BVF can be performed safely and results in reduced residual transvalvular gradients. Performing BVF after VIV TAVR and using larger balloon appears to achieve the best hemodynamic results., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function., Methods: This retrospective cohort study used data from 16 TAVR centres (13,941 patients). The study cohort included 216 patients (72 RTRs and 144 matched controls)., Results: The mean estimated glomerular filtration rate (eGFR) was 39.2 ± 23.6 vs 44.5 ± 23.6 mL/min for RTRs and control patients (P = 0.149), with a similar CKD stage distribution. After TAVR, the eGFR declined among RTRs but remained stable for up to 1 year in controls (P = 0.021). Long-term hemodialysis was required in 19 (26.4%) RTRs and 20 (13.8%) controls (hazard ratio [HR] = 2.09 95% confidence interval [CI], 1.03-3.86; P = 0.039) and was most often initiated during the periprocedural period (14 RTRs vs 16 controls; P = 0.039). After a median follow-up of 2.3 years, risk of death (29.2% vs 31.9%) and death/hemodialysis (40.3% vs 36.8%) was similar between the groups. The contrast volume/eGFR ratio was the strongest predictor of hemodialysis initiation (odds ratio [OR] = 1.64; 95% CI, 1.36-1.97 per 1 unit increase; P < 0.001), with a greater effect among RTRs than controls (P for interaction = 0.022)., Conclusion: s: TAVR appears safe in RTRs with mortality rates similar to matched patients with native kidneys. However, RTRs carry an increased risk of progressive renal impairment and need for hemodialysis initiation after TAVR. Our data highlight the importance of minimizing contrast load during TAVR, particularly in RTRs., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies., Background: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients., Methods: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%., Results: A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R 2 of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth., Conclusions: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses., Background: Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis., Methods: Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses)., Results: Bioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR., Conclusions: Stentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study., Background: Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction., Methods: Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images., Results: Between February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR., Conclusions: BASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk., (Published by Elsevier Inc.)

Coronary artery obstruction is an uncommon but devastating complication of transcatheter aortic valve replacement (TAVR). Computed tomography appears to be a sensitive but nonspecific predictor of coronary artery obstruction. Transcatheter approaches to prevent and treat coronary artery obstruction, such as "snorkel" stenting, are unsatisfactory because of serious early and late ischemic complications. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is an early-stage transcatheter procedure to prevent coronary artery obstruction. It works by splitting the native or bioprosthetic leaflets so that they splay after TAVR and preserve coronary artery inflow. Because of the paucity of suitable alternatives, there is interest in the BASILICA technique despite its infancy. This tutorial review summarizes current thinking about how to predict and prevent coronary artery obstruction using BASILICA. First, the authors depict the main pathophysiological mechanisms of TAVR-associated coronary artery obstruction, along with the factors thought to contribute to coronary obstruction. Next, the authors provide a step-by-step guide to analyzing pre-procedural computed tomographic findings to assess obstruction risk and, if desirable, to plan BASILICA. Next, the authors describe the mechanisms underlying transcatheter electrosurgery. Finally, they provide step-by-step guidance on how to perform the procedure, along with a required equipment list., (Published by Elsevier Inc.)

Objectives: Although many challenges related to the acute implantation of transcatheter aortic valves have been resolved, durability and early degeneration are currently the main concerns. Recent reports indicate the potential for early valve degeneration and calcification. However, only little is known about the underlying mechanisms behind the early degeneration of these valves. The goal of this study was to test whether stent crimping increases the risk for early calcification., Methods: Stented valves that were crimped at 18-Fr and 14-Fr catheter and uncrimped controls were exposed to a standard calcifying solution for 50 million cycles in an accelerated wear test system. Subsequently, the leaflets of the valves were imaged by microcomputed tomography (micro-CT) followed by histochemical staining and microscopic analyses to quantify calcification and other changes in the leaflets' characteristics., Results: Heavily calcified regions were found over the stent-crimped leaflets compared to uncrimped controls, particularly around the stent's struts. Micro-CT studies measured the total volume of calcification in the uncrimped valves as 77.31 ± 1.63 mm3 vs 95.32 ± 5.20 mm3 in 18-Fr and 110.01 ± 8.33 mm3 in 14-Fr stent-crimped valves, respectively. These results were congruent with the increase in leaflet thickness measured by CT scans (0.44 ± 0.07 mm in uncrimped valves vs 0.69 ± 0.15 mm and 0.75 ± 0.09 mm in 18-Fr and 14-Fr stent-crimped valves, respectively). Histological studies confirmed the micro-CT results, denoting that the percentage of calcification in uncrimped leaflets at the valve's posts was 5.34 ± 3.97 compared to 19.97 ± 6.18 and 27.64 ± 13.17 in the 18-Fr and 14-Fr stent-crimped leaflets, respectively., Conclusions: This study concludes that stent-crimping damage is associated with a higher level of passive leaflet calcification, which may contribute to early valve degeneration., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway., Background: Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines., Methods: Patients were enrolled from 6 low-volume (<100 TAVR/year), 4 medium-volume, and 3 high-volume (>200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR., Results: Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15)., Conclusions: Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes., (Copyright © 2019. Published by Elsevier Inc.)

Aortic valve-in-valve is a less invasive alternative to surgical redo in the treatment of failed bioprosthetic valves. While only inoperable patients underwent the procedure before, operators currently offer it to those at lower risk and worldwide experience is in the thousands. Early mortality has diminished in recent analyses and improvements in symptoms and quality of life have been documented. Main considerations with aortic valve-in-valve include elevated postprocedural gradients, coronary obstruction and leaflet thrombosis. Risk factors for each of these adverse events have been described at length. Aortic valve-in-valve offers a safe and effective option in the management of failed bioprosthetic valves., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Transcatheter aortic valve replacement has proven successful in treating intermediate-risk, high-risk, and inoperable patients with severe aortic stenosis. Third-generation, balloon-expandable transcatheter aortic valves were developed with an outer sealing skirt to reduce paravalvular leakage. As transcatheter aortic valve replacement use expands, long-term durability questions remain. Valve design influences durability, where regions of increased leaflet stress are vulnerable to early degeneration. However, third-generation transcatheter aortic valve stresses are unknown. Our goals were to determine the stent and leaflet stresses of third-generation, balloon-expandable transcatheter aortic valves., Methods: The commercial 26-mm Edwards SAPIEN 3 valve (Edwards Lifesciences, Inc, Irvine, Calif) underwent high-resolution micro-computed tomography scanning to develop a precise 3-dimensional geometric mesh of the stent and valve. Leaflet material properties were obtained from surgical bioprostheses, and stent material properties were based on cobalt-chromium. Simulations of systemic pressure loading were performed, and stress was calculated using finite element analyses., Results: At diastole, maximum and minimum principal stresses on transcatheter aortic valve leaflets were 2.7 MPa and -0.47 MPa, respectively. Peak leaflet stresses were observed at upper leaflet commissures, at their connection to the stent. Maximum and minimum principal stresses for the stent were 38.2 MPa and -44.4 MPa, respectively, at 80 mm Hg and were located just below the commissural stent., Conclusions: Stress analysis of the 26-mm SAPIEN 3 valve using exact geometry from high-resolution scans demonstrated that peak stresses for both transcatheter aortic valve stent and leaflets were present at commissural tips where leaflets were attached. These regions would be most likely to initiate degeneration. The Dacron skirt had minimal effect on stresses on leaflets and stent., (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.)

Objective: To determine the safety and efficacy of valve-in-valve transcatheter aortic valve replacement (ViV) versus redo surgical aortic valve replacement (SAVR) for the treatment of previously failed aortic bioprostheses., Background: Valve-in-valve has emerged as a treatment option for patients with a failed aortic bioprosthesis. Evidence for safety and efficacy remains limited to small studies., Methods: Medline and Embase were searched to 2017 for studies that directly compared ViV to redo SAVR. A random effects meta-analysis was performed., Results: Four unadjusted (n = 298) and two propensity-matched (n = 200) observational studies were included. Valve-in-valve patients were 2.85-years older (P = 0.03) and were 23% higher in predicted mortality risk (ratio of means: 1.23, 95% confidence interval (95%CI): 1.02-1.48). There was no difference in peri-operative mortality (4.4% vs. 5.7%, P = 0.83;I 2  = 0%) or late mortality, reported at median one year follow-up (incident rate ratio (IRR) 0.93, 95%CI: 0.74-1.16, P = 0.51, I 2  = 0%) between ViV and redo SAVR. The incidence of permanent pacemaker implantation (8.3% vs 14.6%; P = 0.05;I 2  = 0%) and dialysis (3.2% vs. 10.3%; P = 0.03; I 2  = 0%) were lower in ViV. There was a reduction in the incidence of severe patient-prosthesis mismatch (3.3% vs 13.5%; P = 0.03; I 2  = 0%) and mild or greater paravalvular leak (5.5% vs 21.1%; P = 0.03; I 2  = 37%) in the redo SAVR group compared to ViV., Conclusions: Despite higher predicted surgical risk of ViV patients, there was no difference in mortality but less permanent pacemaker implantation and dialysis compared to redo SAVR. Choice of treatment must be individualized for both anatomical and patient risk factors; in high risk patients with favorable previous prosthesis size, valve-in-valve may be preferred., (© 2018 Wiley Periodicals, Inc.)

Background: Public reporting of hospital-level outcomes is increasingly common as a means to target quality improvement strategies to ensure the delivery of optimal care. Despite the rapid dissemination of transcatheter aortic valve replacement (TAVR), there is a paucity of reliable case-mix adjustment models for hospital profiling in TAVR. Our objective was to develop and evaluate different models for calculating risk-standardized all-cause mortality rates (RSMRs) post-TAVR., Methods and Results: In this population-based study in Ontario, Canada, we identified all patients who underwent a TAVR procedure between April 1, 2012, and March 31, 2016. For each hospital, we calculated 30-day and 1-year RSMR, using 2-level hierarchical logistic regression models that accounted for patient-specific demographic and clinical characteristics, as well as the clustering of patients within the same hospital using a hospital-specific random effects. We classified each hospital into one of 3 groups: performing worse than expected, better than expected, or performing as expected, based on whether the 95% CI of the RSMR was above, below, or included the provincial average mortality rate, respectively. Our cohort consisted of 2129 TAVR procedures performed at 10 hospitals. The observed mortality was 7.0% at 30 days and 16.4% at 1 year, with a range of 4% to 10% and 8% to 22%, respectively, across hospitals. We developed case-mix adjustment models using 28 clinically relevant variables. Using 30-day and 1-year RSMR to profile each hospital, we found that all hospitals performed as expected, with 95% CI that included the provincial average., Conclusions: We found no significant interhospital variation in RSMR among hospitals, suggesting that quality improvement efforts should be directed at aspects other than the variation in observed mortality.

Background: Transcatheter Aortic Valve Implantation (TAVI) is commonly used to deploy new bioprosthetic valves inside degenerated surgically implanted aortic valves in high risk patients. The three scoring systems used to assess risk of postprocedural mortality are: Logistic EuroSCORE (LES), EuroSCORE II (ES II), and Society of Thoracic Surgeons (STS)., Objective: The purpose of this study is to analyze the accuracy of LES, ES II, and STS in estimating all-cause mortality after transcatheter aortic valve-in-valve (ViV) implantations, which was not assessed before., Methods: Using the Valve-in-Valve International Data (VIVID) registry, a total of 1,550 patients from 110 centers were included. The study compared the observed 30-day overall mortality vs. the respective predicted mortalities calculated by risk scores. The accuracy of prediction models was assessed based on calibration and discrimination., Results: Observed mortality at 30 days was 5.3%, while average expected mortalities by LES, ES II and STS were 29.49 (± 17.2), 14.59 (± 8.6), and 9.61 (± 8.51), respectively. All three risk scores overestimated 30-day mortality with ratios of 0.176 (95% CI 0.138-0.214), 0.342 (95% CI 0.264-0.419), and 0.536 (95% CI 0.421-0.651), respectively. 30-day mortality ROC curves demonstrated that ES II had the largest AUC at 0.722, followed by STS at 0.704, and LES at 0.698., Conclusions: All three scores overestimated mortality at 30 days with ES II showing the highest predictability compared to LES and STS; and therefore, should be recommended for ViV procedures. There is a need for a dedicated scoring system for patients undergoing ViV interventions., (© 2018 Wiley Periodicals, Inc.)

Background Limited data exist on clinical valve thrombosis after transcatheter aortic valve-in-valve (ViV) implantation. Our objective was to determine the incidence, timing, clinical characteristics, and treatment outcomes of patients diagnosed with clinical ViV thrombosis. Methods and Results Centers participating in the Valve-in-Valve International Data Registry were surveyed for thrombosis cases, and clinical valve thrombosis was defined based on a combination of the presence of new valve dysfunction and an imaging evidence of leaflet thrombosis. Three hundred ViV implantations were included. The surgical valve was stented in 86.3% and stentless in 13.7% of cases; and the transcatheter heart valve was self-expanding in 50%, balloon-expandable in 49%, and mechanically expanding in 1.0%. The incidence of clinical valve thrombosis was 7.6% (n=23), diagnosed at a median time of 101 days (interquartile range, 21-226) after the procedure. Fifteen patients (65%) presented with worsening symptoms and 21 (91%) with transvalvular mean gradient elevation. The mean gradient at the time of diagnosis (median 39 mm Hg; interquartile range, 30-44) was significantly higher than immediately post-ViV (13 mm Hg; interquartile range, 8-20.5; P<0.001) and was significantly reduced after oral anticoagulation therapy (17.5 mm Hg; interquartile range, 11-20.5; P<0.001). There were no deaths or strokes related to valve thrombosis. Factors associated with valve thrombosis were oral anticoagulation (odds ratio [95% confidence limits]: 0.067 [0.008-0.543], P=0.011), surgical valve true internal diameter indexed to body surface area (0.537 [0.331-0.873], P=0.012), and Mosaic or Hancock II stented porcine bioprostheses (4.01 [1.287-12.485], P=0.017). Conclusions Clinical valve thrombosis after transcatheter aortic ViV implantation is common, especially in patients not on oral anticoagulation. Although aortic ViV is commonly associated with elevated gradients, valve thrombosis should be ruled out if gradients increase compared with early postprocedural values. A higher incidence was observed after treatment of certain stented porcine surgical valve types, suggesting a specific adjustment of the adjunctive antithrombotic therapy in this subset of ViV patients.

An ageing population and increased utilisation of tissue valves in younger patients imply that the number of patients receiving transcatheter aortic valve implantation within failed bioprostheses will continue to increase. There are two major adverse events associated with aortic valve-in-valve procedures that may temper the enthusiasm for these appealing interventions. Residual stenosis is the "Achilles' heel" of aortic valve-in-valve, while coronary obstruction is an uncommon but life-threatening adverse event. Prevention of these adverse events is essential. Emerging tools and techniques enable operators to manipulate existing devices and to implant new ones inside them safely. Considering the available evidence, it seems that bioprosthetic valve ring fracture and bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) may enable some solution. Until we have prosthetic valves that are both very durable and non-thrombogenic, we can expect that techniques and tools chosen to treat failed bioprosthetic valves effectively will continue to be designed and utilised.

Objectives: We sought to determine the impact of aortic root calcium on the risk of significant paravalvular regurgitation (sPAR) in transcatheter aortic valve replacement (TAVR)., Methods: In 302 consecutive patients from 3 centers, aortic root calcium was quantified volumetrically on pre-TAVR multidetector computed tomography (MDCT) in three regions: 1) the aortic valve region, 2) the overall left ventricular outflow tract (LVOT) and 3) the upper LVOT. Transcathether heart valve (THV) oversizing was calculated as (THV nominal area/MDCT annular area-1) × 100. The study endpoint sPAR was a composite of post-dilatation (PD) and PAR > mild., Results: sPAR occurred in 15% (46/302) of patients. Upper LVOT calcium volume was more predictive of sPAR than overall LVOT calcium volume, with an area under the receiver operating curve (AUC) (95% confidence interval [CI]) of 0.80 (0.67-0.89) vs. 0.60 (0.51-0.70); p = 0.0001. The optimal cut-off calcium volume thresholds determined from receiver operating curves were 21 mm 3 and 30 mm 3 for upper LVOT and overall LVOT calcium, respectively. Upper LVOT calcium ≥ 21 mm 3 , but not overall LVOT calcium ≥ 30 mm 3 , independently predicted sPAR, odds ratio (95%CI): 9.5 (4.1-22.3) vs 1.6 (0.6-2.7). Upper LVOT calcium was more predictive of sPAR in patients with THV oversizing ≥ 13% compared to patients with THV oversizing <13%, AUC (95% CI): 0.83 (0.72-0.93) vs. 0.67 (0.51-0.74); p < 0.0001., Conclusions: Upper LVOT calcium predicts more-than-mild paravalvular regurgitation following TAVR or the need for postdilatation. Upper LVOT calcium is most predictive of paravalvular regurgitation in the event of THV oversizing ≥ 13%., (Copyright © 2018 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objective: Aortic valve-in-valve implantation for prosthetic valve dysfunction is a good alternative to reoperative valve replacement. There are some limitations to this approach including the risk of coronary occlusion, patient prosthesis mismatch, and valve malposition. The incidence of coronary occlusion is higher in aortic valve-in-valve than de novo aortic stenosis cases. Multiple factors can contribute to this complication, and the type of bioprosthesis has been implicated., Methods: We examined our experience of 80 aortic valve-in-valve cases with internally and externally mounted leaflet valves., Results: Procedural success was achieved in 95% of cases with an overall 30-day mortality of 1.3%. Clinical and procedural outcomes were similar in the both cohorts., Conclusions: Our data suggest that aortic valve-in-valve implantation can be safely performed in carefully selected patient with internally and externally mounted leaflet bioprosthesis.

Objective: We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event., Methods: A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls)., Results: Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44)., Conclusions: Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation., Competing Interests: Competing interests: DD is a consultant for Edwards Lifesciences, Medtronic and Abbott. SB is a proctor and consultant for Medtronic and a proctor for Boston Scientific and JenaValve. RL is a member of the Medtronic advisory board. SG is a consultant for Edwards Lifesciences, Medtronic, Surmodics, Osprey Medical and Boston Scientific and also repots research grants from Edwards Lifesciences and VA Office of Research and Development. EF reports consulting and proctoring for Edwards Lifesciences. DH is a member of the Medtronic advisory board. TZ reports lecture fees from Edwards Lifesciences and Medtronic. MJR is a consultant for Medtronic, Abbott and Boston Scientific. SW reports institutional research grants from Amgen, Abbott, Boston Scientific, Biotronik and St. Jude Medical. NMvM reports research grant support from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, Claret and Essential Medical. NB has received research grants from Edwards Lifesciences and speaker honoraria from Edwards Lifesciences, Medtronic and Abbott. AC is part of the speakers bureau for Edwards Lifesciences, Medtronic and Abbott, and also reports proctoring for Medtronic. J-MS reports research grants and speaker honoraria from Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. No other conflicts of interest were reported., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: This study sought to develop a novel technique called bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction (BASILICA)., Background: Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR)., Methods: We lacerated pericardial leaflets in vitro using catheter electrosurgery, and tested leaflet splaying after benchtop TAVR. The procedure was tested in swine. BASILICA was then offered to patients at high risk of coronary obstruction from TAVR and ineligible for surgical aortic valve replacement. BASILICA used marketed devices. Catheters directed an electrified guidewire to traverse and lacerate the aortic leaflet down the center line. TAVR was performed as usual., Results: TAVR splayed lacerated bovine pericardial leaflets. BASILICA was successful in pigs, both to left and right cusps. Necropsy revealed full length lacerations with no collateral thermal injury. Seven patients underwent BASILICA on a compassionate basis. Six had failed bioprosthetic valves, both stented and stent-less. Two had severe aortic stenosis, including 1 patient with native disease, 3 had severe aortic regurgitation, and 2 had mixed aortic valve disease. One patient required laceration of both left and right coronary cusps. There was no hemodynamic compromise in any patient following BASILICA. All patients had successful TAVR, with no coronary obstruction, stroke, or any major complications. All patients survived to 30 days., Conclusions: BASILICA may durably prevent coronary obstruction from TAVR. The procedure was successful across a range of presentations, and requires further evaluation in a prospective trial. Its role in treatment of degenerated TAVR devices remains untested., (Published by Elsevier Inc.)

Objectives: The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size)., Background: Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation., Methods: Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm 2 /m 2 if body mass index is <30 kg/m 2 and <0.6 cm 2 /m 2 if BMI is ≥30 kg/m 2 . The primary study endpoint was 1-year mortality., Results: Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg)., Conclusions: Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the association between markers of precapillary pulmonary hypertension (PH) and survival in transcatheter aortic valve replacement (TAVR)., Background: The importance of precapillary PH has been sparsely investigated in patients undergoing TAVR. It may prove an important risk factor for poor outcomes., Methods: We identified patients at our institution undergoing TAVR with a baseline right heart catheterization (RHC) demonstrating PH. We evaluated the association between markers of precapillary PH and survival including the diastolic pulmonary gradient (DPG), transpulmonary gradient (TPG), and pulmonary vascular resistance (PVR). A multivariable analysis was performed using Cox Proportional Hazards Models, adjusting for age, gender, body mass index, and pulmonary artery systolic pressure (PASP) on echocardiography., Results: We identified 133 patients with PH on RHC. Of these 111 had low DPG and 22 had high DPG. All 3 markers of precapillary PH were associated with worse survival post TAVR, with OR of 2.1 (95% CI 1.1-3.9, P = 0.02), 3.4 (95% CI 1.8-6.4, P < 0.001) and 2.5 (95% CI 1.4-4.5, P = 0.003) for high DPG, TPG, and PVR, respectively. On multivariable analysis, both TPG and PVR remained predictors of worse survival, with OR of 3.4 (95% CI 1.7-6.9, P = 0.001) and 2.5 (95% CI 1.4-4.5, P = 0.003). Echocardiographic PASP and DPG were not predictive of survival., Conclusions: In patients undergoing TAVR, parameters of precapillary PH are associated with lower survival, and provide incremental prognostication over echocardiographic PASP. RHC should continue to play an important role in risk stratification prior to TAVR. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Objectives: Prosthetic leaflet thrombosis is a growing concern in transcatheter aortic valve replacement (TAVR). Given the uncertainty of best practices for antiplatelet and anticoagulation therapies in the post-TAVR period, additional evidence regarding the impact of anticoagulation on prosthetic valve function after TAVR is needed., Methods: Patients undergoing native-valve TAVR at a single academic institution between 2012 and 2015 were analyzed based on any anticoagulant use at hospital discharge post TAVR. Changes in prosthetic valve peak velocity and mean gradient were assessed based on transthoracic echocardiograms performed immediately following valve implant and at 4-week follow-up. Multivariate regression analyses were performed to explore the impact of anticoagulation status on early TAVR valve performance., Results: For 403 patients, there were no available data to analyze. Of those, 29.6% were discharged on anticoagulation. Following TAVR, the average mean prosthetic valve gradient was 11.8 ± 5.6 mm Hg and peak velocity was 2.33 ± 0.52 m/s. There were no significant differences between anticoagulated and non-anticoagulated groups in the mean or peak gradients or velocity immediately following implant or at 4 weeks, which remained true following multivariate adjustment (P=.80 for delta mean gradient; P=.91 for delta peak velocity)., Conclusion: Our data suggest that the absence of anticoagulation is not associated with short-term degradation in TAVR performance and do not support the routine use of anticoagulation following native-valve TAVR.

Aims: There is an increasing awareness of leaflet thrombosis following transcatheter aortic valve implantation (TAVI) and valve-in-valve (ViV) procedures. Nevertheless, the predisposing factors affecting transcatheter aortic valve (TAV) thrombosis have remained unclear. This study aimed to quantify the effects of reduced cardiac output (CO) on blood stasis on the TAV leaflets as a permissive factor for valve thrombosis., Methods and Results: An idealised computational model representing a TAV was developed in a patient-specific geometry. Three-dimensional flow fields were obtained via a fluid-solid interaction modelling approach at different COs: 5.0, 3.5, 2.0 L/min. Blood residence time (BRT) was subsequently calculated on the leaflets. An association between reduced CO and increased blood stasis on the TAV leaflets was observed. At the end of diastole, larger areas of high BRT (>1.2 s) were observed at the leaflet's fixed edge at low COs. Such areas were calculated to be 2, 8, and 11% of the total surface area of leaflets at CO=5.0, 3.5, and 2.0 L/min, respectively, indicating a ~sixfold increase of BRT on the leaflets from the highest to the lowest CO., Conclusions: This study indicates an association between reduced CO and increased blood stasis on the TAV leaflets which can be regarded as a precursor of valve thrombosis.

Background: Leaflet thrombosis after valve-in-valve (ViV) procedure has been increasingly recognized. This study aimed to investigate the flow dynamics aspect of leaflet thrombosis by quantifying the blood stasis on the noncoronary and coronary leaflets of a surgical aortic valve (SAV) and a transcatheter aortic valve (TAV) in a ViV setting., Methods: Two computational models, representing a SAV and a TAV in ViV setting, were developed in a patient-specific geometry. Three-dimensional flow fields were obtained through a fluid-solid interaction modeling approach to study the difference in blood residence time (BRT) on the coronary and noncoronary leaflets., Results: Longer BRT was observed on the TAV leaflets compared with the SAV, specifically near the leaflet fixed boundary. Particularly, at the end of diastole, the areas of high BRT (≥1.2 seconds) on the surface of the TAV model leaflets were four times larger than those of the SAV model. The distribution of BRT on the three leaflets exhibited a similar pattern in the model for the TAV in ViV setting. That was in contrast to the SAV model where large areas of high BRT were observed on the noncoronary leaflet., Conclusions: Geometric confinement of the TAV by the leaflets and the frame of the degenerated bioprosthesis that circumferentially surround the TAV stent increases the BRT on the leaflets, which may act as a permissive factor in the TAV leaflet thrombosis after ViV procedure. A similar distribution pattern of BRT observed on the TAV leaflets may explain the similar rate of occurrence of thrombosis on the three leaflets., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Equipoise of transcatheter aortic valve replacement with surgical aortic valve replacement in intermediate-risk patients has been demonstrated. As transcatheter aortic valve replacement usage expands, questions regarding long-term durability become paramount. Valve design impacts durability with regions of increased leaflet stress being vulnerable to early failure. However, transcatheter aortic valve (TAV) leaflet stresses are unknown. The objective of this study was to determine stent and leaflet stresses of second-generation balloon-expandable TAV., Methods: Commercial 29-mm Edwards Sapien XT (Edwards Lifesciences, Irvine, CA) valves underwent high-resolution microcomputed tomography scanning to develop precise three-dimensional geometric mesh. Compressed and uncompressed TAVs were modeled under systemic pressure using finite element software. Material properties of stent were based on cobalt-chromium, whereas those for leaflets were obtained from surgical bioprostheses., Results: Maximum and minimum principal stresses on uncompressed Sapien XT TAV were 1.63 MPa and -0.36 MPa on leaflets and 93.3 MPa and -105.6 MPa on stent at diastolic pressure. Peak leaflet stress was observed at commissural tips where leaflets connected to the stent. For compressed TAV to 26 mm, maximum and minimum principal stresses were 1.55 MPa and -0.63 MPa on leaflets and 526.1 MPa and -902.2 MPa on stent at diastolic pressure. Peak leaflet stress was located at similar position and also along the suture line with the Dacron (C. R. Bard, Haverhill, PA)., Conclusions: Stress analysis of two extreme deployed geometries of 29-mm Edwards Sapien XT using exact geometry from high-resolution scans demonstrated that peak stresses for TAV leaflets were present at commissural tips where leaflets were attached. These regions would be mostly likely to initiate degeneration., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine if indexed effective orifice area (EOAi), using left ventricular outflow tract measured from computed tomography (EOAi CT ), reclassified prosthesis-patient mismatch (PPM) compared with conventional echocardiogram-defined measurements (EOAi TTE )., Background: PPM does not predict mortality following transcatheter aortic valve replacement (TAVR). However, it is unknown if the EOAi CT of the left ventricular outflow tract improves risk stratification., Methods: A total of 765 TAVR patients from the PARTNER II (Placement of Aortic Transcatheter Valves II) trial S3i cohort were evaluated. EOAi was calculated using the continuity equation, and the left ventricular outflow tract area was derived from baseline computed tomography. Traditional echocardiographic categories defined PPM: absent (>0.85 cm 2 /m 2 ), moderate (≥0.65 and ≤0.85 cm 2 /m 2 ), or severe (≤0.65 cm 2 /m 2 ). Correlation of EOAi CT and EOAi TTE to 1-year outcomes was performed., Results: The incidence of PPM was 24% with EOA CT compared with 45% with EOAi TTE . Only 6% of PPM was graded severe by EOAi CT compared with 9% by EOAi TTE . EOAi TTE , but not EOAi CT , defined PPM showed association with reduced left ventricular mass regression (p = 0.03 vs. p = 0.52). There was no association between PPM and death or rehospitalization at 1 year with either modality. EOA CT was associated with minor stroke at 1 year (log-rank p = 0.04), and EOAi TTE with stroke/transient ischemic attack (log-rank p = 0.030). Furthermore, when subjects with mild or greater paravalvular regurgitation were excluded, the presence of PPM did not show association with any outcome., Conclusions: EOAi CT downgrades frequency and severity of PPM in patients after TAVR, and was not associated with mortality 1 year after TAVR. EOAi TTE , but not EOAi CT , was associated with less left ventricular mass regression., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) may be less effective in small surgical valves because of patient/prosthesis mismatch. Bioprosthetic valve fracture (BVF) using a high-pressure balloon can be performed to facilitate VIV TAVR., Methods and Results: We report data from 20 consecutive clinical cases in which BVF was successfully performed before or after VIV TAVR by inflation of a high-pressure balloon positioned across the valve ring during rapid ventricular pacing. Hemodynamic measurements and calculation of the valve effective orifice area were performed at baseline, immediately after VIV TAVR, and after BVF. BVF was successfully performed in 20 patients undergoing VIV TAVR with balloon-expandable (n=8) or self-expanding (n=12) transcatheter valves in Mitroflow, Carpentier-Edwards Perimount, Magna and Magna Ease, Biocor Epic and Biocor Epic Supra, and Mosaic surgical valves. Successful fracture was noted fluoroscopically when the waist of the balloon released and by a sudden drop in inflation pressure, often accompanied by an audible snap. BVF resulted in a reduction in the mean transvalvular gradient (from 20.5±7.4 to 6.7±3.7 mm Hg, P <0.001) and an increase in valve effective orifice area (from 1.0±0.4 to 1.8±0.6 cm 2 , P <0.001). No procedural complications were reported., Conclusions: BVF can be performed safely in small surgical valves to facilitate VIV TAVR with either balloon-expandable or self-expanding transcatheter valves and results in reduced residual transvalvular gradients and increased valve effective orifice area., (© 2017 American Heart Association, Inc.)

Objective: Transcatheter heart valve implantation in failed aortic bioprostheses (valve-in-valve [ViV]) is an increasingly used therapeutic option for high-risk patients. However, high postprocedural gradients are a significant limitation of aortic ViV. Our objective was to evaluate Medtronic CoreValve Evolut R ViV hemodynamics in relation to the degree of device oversizing and depth of implantation., Methods: Evolut R devices of 23 and 26 mm were implanted within 21-, 23-, and 25-mm Hancock II bioprostheses. Small and gradual changes in implantation depth were attempted. Hemodynamic testing was performed in a pulse duplicator under ISO-5840 standard., Results: A total of 47 bench-testing experiments were performed. The mean gradient of the 26-mm Evolut R in 23- and 25-mm Hancock II was lower than 23-mm Evolut R (P < .001). However, the mean gradient of 26-mm Evolut R in 21-mm Hancock II bioprostheses R (ranging from 21.30 ± 0.23 to 24.30 ± 0.22 mm Hg) was worse than 23-mm Evolut R (ranging from 15.94 ± 0.18 to 20.35 ± 0.16 mm Hg, P < .001). Furthermore, our results suggest that supra-annular implantation of 23-mm and 26-mm Evolut R devices within the bioprostheses can lead to lower gradient and improved leaflet coaptation. Regardless of implantation depth, superior transvalvular gradient is expected with 26-mm Evolut R than 23-mm Evolut R in a nonstenotic Hancock II with a true internal diameter > 17.5 mm., Conclusions: The current comprehensive bench-testing assessment demonstrates the importance of both transcatheter heart valve size and device position for the attainment of optimal hemodynamics during ViV procedures. Additional in vitro testing may be required to develop hemodynamics-based guidelines for device sizing in ViV procedures in degenerated surgical bioprostheses., (Copyright © 2017 The American Association for Thoracic Surgery. 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.)

Background: Early experience with transcatheter aortic valve replacement (TAVR) within failed bioprosthetic surgical aortic valves has shown that valve-in-valve (VIV) TAVR is a feasible therapeutic option with acceptable acute procedural results., Objectives: The authors examined 30-day and 1-year outcomes in a large cohort of high-risk patients undergoing VIV TAVR., Methods: Patients with symptomatic degeneration of surgical aortic bioprostheses at high risk (≥50% major morbidity or mortality) for reoperative surgery were prospectively enrolled in the multicenter PARTNER (Placement of Aortic Transcatheter Valves) 2 VIV trial and continued access registries., Results: Valve-in-valve procedures were performed in 365 patients (96 initial registry, 269 continued access patients). Mean age was 78.9 ± 10.2 years, and mean Society of Thoracic Surgeons score was 9.1 ± 4.7%. At 30 days, all-cause mortality was 2.7%, stroke was 2.7%, major vascular complication was 4.1%, conversion to surgery was 0.6%, coronary occlusion was 0.8%, and new pacemaker insertion was 1.9%. One-year all-cause mortality was 12.4%. Mortality fell from the initial registry to the subsequent continued access registry, both at 30 days (8.2% vs. 0.7%, respectively; p = 0.0001) and at 1 year (19.7% vs. 9.8%, respectively; p = 0.006). At 1 year, mean gradient was 17.6 mm Hg, and effective orifice area was 1.16 cm 2 , with greater than mild paravalvular regurgitation of 1.9%. Left ventricular ejection fraction increased (50.6% to 54.2%), and mass index decreased (135.7 to 117.6 g/m 2 ), with reductions in both mitral (34.9% vs. 12.7%) and tricuspid (31.8% vs. 21.2%) moderate or severe regurgitation (all p < 0.0001). Kansas City Cardiomyopathy Questionnaire score increased (mean: 43.1 to 77.0) and 6-min walk test distance results increased (mean: 163.6 to 252.3 m; both p < 0.0001)., Conclusions: In high-risk patients, TAVR for bioprosthetic aortic valve failure is associated with relatively low mortality and complication rates, improved hemodynamics, and excellent functional and quality-of-life outcomes at 1 year. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves [PARTNER II]; NCT01314313)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of the study was to investigate the influence of the extent of computed tomography (CT)-based area and perimeter oversizing on the incidence and severity of paravalvular aortic regurgitation (PAR) for the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) device, using CT data and echocardiographic outcome data of the PARTNER II (Placement of AoRTic TraNscathetER Valves Trial II) SAPIEN 3 intermediate-risk cohort., Background: Transcatheter heart valve (THV) sizing algorithms are device specific, requiring refinements for new valve designs., Methods: A total of 835 intermediate-risk patients with severe, symptomatic aortic stenosis enrolled in a multicenter, nonrandomized registry at 57 sites in the United States and Canada with available systolic CT data and echocardiographic follow-up were included in this analysis. THV size selection was primarily CT guided based on annular area. Area-based and perimeter-based oversizing was calculated using systolic annular CT dimensions and nominal dimensions of the implanted THV size. PAR was assessed at 30 days according to a 5-class scheme., Results: Mean oversizing by area was 7.7 ± 9.4% and mean oversizing by perimeter was 1.7 ± 4.4%. An inverse proportional relationship between degree of oversizing and frequency and severity of PAR was observed for both area and perimeter oversizing. Perimeter and area oversizing confer similar predictive capacity in regard to the occurrence of PAR after THV implantation (area under the curve: 0.78 [95% confidence interval: 0.70 to 0.85] vs. area under the curve: 0.78 [95% confidence interval: 0.72 to 0.85]; p < 0.0001). No aortic root ruptures were observed., Conclusions: For the SAPIEN 3 THV, the frequency and extent of PAR is inversely related to the degree of oversizing with acceptable rates of PAR being achieved at lower degrees of oversizing. Perimeter and area oversizing confer similar predictive capacity in regard to the occurrence of PAR after implantation of the SAPIEN 3 THV. Therefore, the SAPIEN 3 THV may offer the opportunity to reduce the risk of annular rupture associated with more significant degrees of oversizing in borderline annular anatomy. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves [PARTNER II]; NCT01314313)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV)., Methods and Results: Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm 2 ; P =0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P =0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P =0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P =0.03)., Conclusions: In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation., (© 2017 American Heart Association, Inc.)

Aims: The aim of this study was to examine the short- and medium-term outcomes of transcatheter aortic valve replacement (TAVR) with the self-expanding and repositionable Portico valve (St. Jude Medical, St. Paul, MN, USA)., Methods and Results: A total of 57 patients underwent TAVR with the Portico valve between March 2012 and August 2014, representing the first-in-human experience and the entire early experience in Canada. Patients were followed up at 30 days and one year with repeat echocardiography and clinical review. Patients were 80.8±7.3 years of age, and the Society of Thoracic Surgeons predicted risk of mortality was 7.7±5.7%. All patients had a valve implanted and four patients (7%) required a second valve. At 30 days, there were two deaths (3.5%), three disabling strokes (5.3%), and new pacemakers in five (8.8%) patients. Echocardiography revealed moderate/severe aortic regurgitation in two patients (3.6%). At one year, survival was 84.2% and echocardiographic findings were unchanged., Conclusions: Transcatheter aortic valve replacement with the repositionable Portico valve provides satisfactory short- and medium-term haemodynamic and clinical results.

Valve-in-valve implantation of a transcatheter heart valve into a failed bioprosthetic heart valve has emerged as a treatment alternative to repeat conventional surgery. This requires careful pre-procedural assessment using non-invasive imaging to identify patients at risk for procedure related adverse events, such as ostial coronary occlusion. Herein we report how to comprehensively assess aortic root anatomy using computed tomography prior to transcatheter valve implantation for failed bioprosthetic aortic valves., (Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

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.)

Aims: Transcatheter heart valve (THV) implantation in failed bioprosthetic valves (valve-in-valve [ViV]) offers an alternative therapy for high-risk patients. Elevated post-procedural gradients are a significant limitation of aortic ViV. Our objective was to assess the relationship between depth of implantation and haemodynamics., Methods and Results: Commercially available THVs used for ViV were included in the analysis (CoreValve Evolut, SAPIEN XT and the Portico valve). THVs were implanted in small surgical valves (label size 19 mm) to simulate boundary conditions. Custom-mounted pulse duplicators registered relevant haemodynamic parameters. Twenty-eight experiments were performed (13 CVE, 5 SXT and 10 Portico). Ranges of depth of implantation were: CVE: -1.2 mm to 15.7 mm; SXT: -2.2 mm to 7.5 mm; Portico: 1.4 mm to 12.1 mm. Polynomial regression established a relationship between depth of implantation and valvular mean gradients (CVE: p<0.001; SXT: p=0.01; Portico: p=0.002), as well as with EOA (CVE: p<0.001; SXT: p=0.02; Portico valve: p=0.003). In addition, leaflet coaptation was better in the high implantation experiments for all valves., Conclusions: The current comprehensive bench testing assessment demonstrates the importance of high device position for the attainment of optimal haemodynamics during aortic ViV procedures.

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.)