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Background: Transcatheter aortic valve replacement (TAVR) has become the standard of care for severe aortic stenosis treatment. Exponential growth in demand has led to prolonged wait times and adverse patient outcomes. Social marginalization may contribute to adverse outcomes. Our objective was to examine the association between different measures of neighborhood-level marginalization and patient outcomes while on the TAVR waiting list. A secondary objective was to understand if sex modifies this relationship., Methods and Results: We conducted a population-based retrospective cohort study of 11 077 patients in Ontario, Canada, referred to TAVR from April 1, 2018, to March 31, 2022. Primary outcomes were death or hospitalization while on the TAVR wait-list. Using cause-specific Cox proportional hazards models, we evaluated the relationship between neighborhood-level measures of dependency, residential instability, material deprivation, and ethnic and racial concentration with primary outcomes as well as the interaction with sex. After multivariable adjustment, we found a significant relationship between individuals living in the most ethnically and racially concentrated areas (quintile 4 and 5) and mortality (hazard ratio [HR], 0.64 [95% CI, 0.47-0.88] and HR, 0.73 [95% CI, 0.53-1.00], respectively). There was no significant association between material deprivation, dependency, or residential instability with mortality. Women in the highest ethnic or racial concentration quintiles (4 and 5) had significantly lower risks for mortality (HR values of 0.52 and 0.56, respectively) compared with quintile 1., Conclusions: Higher neighborhood ethnic or racial concentration was associated with decreased risk for mortality, particular for women on the TAVR waiting list. Further research is needed to understand the drivers of this relationship.

Background: Based on worldwide registries, approximately 50% of patients who underwent aortic valve replacement (AVR) via surgical aortic valve replacement are females. Although AVR procedures have improved greatly in recent years, differences in outcome including mortality between sexes remain. We aimed to investigate the trends in SAVR outcomes in females versus males., Methods: Using the 2011-2017 National Inpatient Sample (NIS) database, we identified hospitalizations for patients with diagnosis of aortic stenosis during which SAVR was performed. Patients' sociodemographic and clinical characteristics, procedure complications, and mortality were analyzed. Piecewise regression analyses were performed to assess temporal trends in SAVR utilization in females versus males. Multivariable analyses were performed to identify predictors of in-hospital mortality., Results: A total of 392,087 hospitalizations for SAVR across the USA were analyzed. Utilization of SAVR in both sex patients decreased significantly during the years 2011-2017. Males compared to females had significantly higher rates of hyperlipidemia, chronic renal disease, peripheral artery disease, coronary artery disease and tended to be smokers. Differences in mortality rates among sexes were observed for SAVR procedures. Women had higher in-hospital mortality with 3.7% compared to men with 2.5% (OR 1.38 [95% CI 1.33-1.43, P<0.001]). In a multivariable regression model analysis adjusted for potential confounders, women had higher mortality risk with odd ratio (OR 1.38 [95% CI 1.33-1.43], P<0.001). Women had significantly higher rates of vascular complications (5.1% compared to men with 4.6%, P=0.002)., Conclusions: Utilization of SAVR showed a downward trend during the study period. Higher in-hospital mortality was recorded in females compared to males.

Background: Transcatheter aortic valve implantation (TAVI) has seen indication expansion and thus exponential growth in demand over the past decade. In many jurisdictions, the growing demand has outpaced capacity, increasing wait times and preprocedural adverse events. In this study, we derived prediction models that estimate the risk of adverse events on the waitlist and developed a triage tool to identify patients who should be prioritized for TAVI., Methods and Results: We included adult patients in Ontario, Canada referred for TAVI and followed up until one of the following events first occurred: death, TAVI procedure, removal from waitlist, or end of the observation period. We used subdistribution hazards models to find significant predictors for each of the following outcomes: (1) all-cause death while on the waitlist; (2) all-cause hospitalization while on the waitlist; (3) receipt of urgent TAVI; and (4) a composite outcome. The median predicted risk at 12 weeks was chosen as a threshold for a maximum acceptable risk while on the waitlist and incorporated in the triage tool to recommend individualized wait times. Of 13 128 patients, 586 died while on the waitlist, and 4343 had at least 1 hospitalization. A total of 6854 TAVIs were completed, of which 1135 were urgent procedures. We were able to create parsimonious models for each outcome that included clinically relevant predictors., Conclusions: The Canadian TAVI Triage Tool (CAN3T) is a triage tool to assist clinicians in the prioritization of patients who should have timely access to TAVI. We anticipate that the CAN3T will be a valuable tool as it may improve equity in access to care, reduce preventable adverse events, and improve system efficiency.

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Aortic stenosis is the most common valvular disease. Surgical aortic valve replacement (SAVR) using mechanical valves has been the preferred treatment for younger patients, but bioprosthetic valves are gaining favour to avoid anticoagulation with warfarin. Transcatheter aortic valve replacement (TAVR) was approved in recent years for the treatment of severe aortic stenosis in intermediate- and low-risk patients as an alternative to SAVR. The longer life expectancy of these groups of patients might exceed the durability of the TAVR or SAVR bioprosthetic valves. Therefore, many patients need 2 or even 3 interventions during their lifetime. Because it has important implications on the feasibility of subsequent procedures, the decision between opting for SAVR or TAVR as the primary procedure requires thorough consideration by the heart team, incorporating patient preferences, clinical indicators, and anatomic aspects. If TAVR is favoured initially, selecting the valve type and determining the implantation level should be conducted, aiming for positive outcomes in the index intervention and keeping in mind the potential for subsequent TAVR-in-TAVR procedures. When SAVR is selected as the primary procedure, the operator must make choices regarding the valve type and the potential need for aortic root enlargement, with the intention of facilitating future valve-in-valve interventions. This narrative review examines the existing evidence concerning the lifelong management of severe aortic stenosis, delving into available treatment strategies, particularly emphasising the initial procedure's selection and its impact on subsequent interventions., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Conduction disturbances and the need for permanent pacemaker (PPM) implantation remains a common complication for transcatheter aortic valve replacement (TAVR), particularly when self-expanding (SE) valves are used., Aims: We compared in-hospital and 30-day rates of new PPM implantation between patients undergoing TAVR with SE valves using the conventional three-cusp coplanar implantation technique and the cusp-overlap technique., Methods: We retrospectively compared patients without a pre-existing PPM who underwent a TAVR procedure with SE Evolut R or PRO valves using the cusp-overlap technique from July 2018 to September 2020 (n = 519) to patients who underwent TAVR using standard three-cusp technique from April 2016 to March 2017 (n = 128) in two high volume Canadian centers., Results: There was no significant difference in baseline RBBB between the groups (10.4% vs. 13.2; p = 0.35). The rate of in-hospital new complete heart block (9.4% vs. 23.4%; p ≤ 0.001) and PPM implantation (8% vs. 21%; p ≤ 0.001) were significantly reduced when using the cusp-overlap technique. The incidence of new LBBB (30.4% vs. 29%; p = 0.73) was similar. At 30 days, the rates of new complete heart block (11% vs. 23%; p ≤ 0.001) and PPM implantation (10% vs. 21%, p ≤ 0.001) remained significantly lower in the cusp-overlap group, while the rate of new LBBB (35% vs. 30%; p = 0.73) was similar., Conclusion: Cusp-overlap approach offers several potential technical advantages compared to standard three-cusp view, and may result in lower PPM rates in TAVR with SE Evolut valve., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Cumulative costs of transcatheter aortic valve replacement (TAVR) differ in the referral, procedural and postprocedural phases depending on patient comorbidities, type of procedure, and procedural complications. Our goal was to determine the association between neighborhood measures of social deprivation and TAVR costs in each of the 3 phases., Methods: Demographics, patient comorbidities, procedural details, in-hospital complications, and costs for adults undergoing TAVR between 2017 and 2020 in Ontario, Canada were obtained from administrative databases and linked to social deprivation data using the Ontario Marginalization Index. The 3 dimensions of social deprivation assessed were (1) material deprivation, (2) residential instability, and (3) ethnic concentration. Hierarchical generalized linear models were used to determine the association between neighborhood social deprivation and cumulative TAVR costs, reported in 2018 Canadian dollars., Results: We identified a total of 7617 TAVR referrals with 3784 patients undergoing TAVR within our study period. Cumulative mean costs in the referral, procedural and postprocedural phases were $8116±$11 374, $32 790±$17 766, and $18 901±$32 490, respectively. After adjustment for clinical and demographic variables, higher factor scores in residential instability were associated with greater cumulative costs in the postprocedural phase, whereas higher factor scores in the other 2 dimensions of marginalization were not significantly associated with higher costs in any of the 3 phases., Conclusions: This analysis shows that residential instability is associated with higher cumulative costs in the postprocedural phase of TAVR. This lays the foundation for future studies to understand the mechanism of this finding and identify potential mitigation policies., Competing Interests: Disclosures None.

Background: Transcatheter aortic valve replacement (TAVR) has become the standard of care for a wide spectrum of patients with severe aortic stenosis. However, there are wide variations in access to TAVR among jurisdictions. It is unknown if such variation is associated with differences in postprocedural outcomes. Our objective was to determine whether differences in health care delivery in jurisdictions with high vs low access of care to TAVR translate to differences in postprocedural outcomes., Methods: In this observational, retrospective cohort study, we identified all Ontario and New York State residents greater than 18 years of age who received TAVR from January 1, 2012, to December 31, 2018. Our primary outcomes were post-TAVR 30 day in-hospital mortality and all-cause readmissions. Using indirect standardization, we calculated the observed vs expected outcomes for New York patients, had they been treated in Ontario., Results: Our cohort consisted of 16,814 TAVR patients at 36 hospitals in New York State and 5007 TAVR patients at 11 hospitals in Ontario. In Ontario, TAVR access rates increased from ∼18.2 TAVR per million in 2012 to 87.4 TAVR per million in 2018, whereas for New York State, the rates increased from 31.9 to 220.4 TAVR per million. For 30-day mortality, 3.1% of Ontario TAVR patients had an in-hospital death, compared with 2.5% of New York patients. With adjustment, this translated to an observed-expected ratio of 0.70 (95% confidence interval [CI], 0.54-0.92) for New York patients., Conclusions: Having greater access to TAVR may be associated with improved outcomes, potentially because of intervention earlier in the trajectory of the disease., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Aortic stenosis (AS) is a serious and complex condition, for which optimal management continues to evolve rapidly. An understanding of current clinical practice guidelines is critical to effective patient care and shared decision-making. This state of the art review of the 2021 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines and 2020 American College of Cardiology/American Heart Association Guidelines compares their recommendations for AS based on the evidence to date. The European and American guidelines were generally congruent with the exception of three key distinctions. First, the European guidelines recommend intervening at a left ventricular ejection fraction of 55%, compared with 60% over serial imaging by the American guidelines for asymptomatic patients. Second, the European guidelines recommend a threshold of ≥65 years for surgical bioprosthesis, whereas the American guidelines employ multiple age categories, providing latitude for patient factors and preferences. Third, the guidelines endorse different age cut-offs for transcatheter vs. surgical aortic valve replacement, despite limited evidence. This review also discusses trends indicating a decreasing proportion of mechanical valve replacements. Finally, the review identifies gaps in the literature for areas including transcatheter aortic valve implantation in asymptomatic patients, the appropriateness of Ross procedures, concomitant coronary revascularization with aortic valve replacement, and bicuspid AS. To summarize, this state of the art review compares the latest European and American guidelines on the management of AS to highlight three areas of divergence: timing of intervention, valve selection, and surgical vs. transcatheter aortic valve replacement criteria., Competing Interests: Conflict of interest: G.B.-Z. has consulted for Cardionovum, Crannmedical, Innovheart, Guidotti, Meditrial, Opsens Medical, Replycare, Teleflex, and Terumo. D.Y.T. has consulted for Medtronics Inc (Canada) and Edwards Life Sciences (Canada). M.G. has received research grants from the Canadian Institute of Health Research and the National Institute of Health. S.F. has received grants from the the Canadian Institute of Health Research and is the site co-Principal Investigator for the Medtronic SURTAVI, Medtronic Low Risk, and Boston NeoAccurate IDE trials. The other authors have no conflicts to disclose., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background Transcatheter aortic valve replacement (TAVR)/intervention has become the standard of care for treatment of severe aortic stenosis across the spectrum of risk. There are socioeconomic disparities in access to TAVR. The impact of these disparities on postprocedural outcomes remains unknown. Our objective was to examine the association between neighborhood-level social deprivation and post-TAVR mortality and hospital readmission. Methods and Results We conducted a population-based retrospective cohort study of all 4145 patients in Ontario, Canada, who received TAVR from April 1, 2017, to March 31, 2020. Our co-primary outcomes were 1-year postprocedure mortality and 1-year postprocedure readmission. Using Cox proportional hazards models for mortality and cause-specific competing risk hazard models for readmission, we evaluated the relationship between neighborhood-level measures of residential instability, material deprivation, and concentration of racial and ethnic groups with post-TAVR outcomes. After multivariable adjustment, we found a statistically significant relationship between residential instability and postprocedural 1-year mortality, ranging from a hazard ratio of 1.64 to a hazard ratio of 2.05. There was a significant association between the highest degree of residential instability and 1-year readmission (hazard ratio, 1.23 [95% CI, 1.01-1.49]). There was no association between material deprivation and concentration of racial and ethnic groups with post-TAVR outcomes. Conclusions Residential instability was associated with increased risk for post-TAVR mortality, and the highest quintile of residential instability was associated with increased post-TAVR readmission. To reduce health disparities and promote an equitable health care system, further research and policy interventions will be required to identify and support economically and socially minoritized patients undergoing TAVR.

Background: Wide geographic variation in access to transcatheter (TAVR) and surgical (SAVR) aortic valve replacement exists, but the impact of socioethnic factors on the geographic variation of AS management in Ontario, Canada, is unknown., Methods: Neighbourhood rates of AS admissions, as a proxy for AS burden, and downstream TAVR and SAVR referrals and procedures were estimated for the 76 subregions in Ontario. To determine if the socioethnic geographic variations in referrals and procedures were concordant or discordant with AS burden, we calculated Pearson correlation coefficients to determine the relationship between AS burden and each of TAVR referrals, TAVR procedures, SAVR referrals, or SAVR procedures. We developed generalised linear models to determine the association between social deprivation indices captured in the Ontario Marginalization index and the rates of AS burden as well as TAVR/SAVR referral and procedures., Results: There was wide geographic variation that was concordant between AS burden and the referral and procedure rates for TAVR and SAVR (correlation coefficients 0.86-0.96). Increased dependency was associated with higher rates of both TAVR/SAVR referrals and procedures (rate ratios 1.63-2.22). Neighbourhoods with a higher concentration of ethnic minorities were associated with lower AS burden as well as lower rates of both SAVR and TAVR referrals and procedures (rate ratios 0.57-0.85)., Conclusions: An important ethnic gradient exists in AS burden and in both referral and completion of TAVR and SAVR in Ontario. Further research is necessary to understand if this gradient is appropriate or requires mitigation., (Copyright © 2022 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Frailty instruments may improve prognostic estimates for patients undergoing transcatheter aortic valve implantation (TAVI). Few studies have evaluated and compared the performance of administrative database frailty instruments for patients undergoing TAVI. This study aimed to examine the performance of administrative database frailty instruments in predicting clinical outcomes and costs in patients who underwent TAVI., Methods: We conducted a historical cohort study of 3,848 patients aged 66 yr or older who underwent a TAVI procedure in Ontario, Canada from 1 April 2012 to 31 March 2018. We used the Johns Hopkins Adjusted Clinical Group (ACG) frailty indicator and the Hospital Frailty Risk Score (HFRS) to assign frailty status. Outcomes of interest were in-hospital mortality, one-year mortality, rehospitalization, and healthcare costs. We compared the performance of the two frailty instruments with that of a reference model that adjusted baseline covariates and procedural characteristics. Accuracy measures included c-statistics, Akaike information criterion (AIC), Bayesian information criterion (BIC), integrated discrimination improvement (IDI), net reclassification index (NRI), bias, and accuracy of cost estimates., Results: A total of 863 patients (22.4%) were identified as frail using the Johns Hopkins ACG frailty indicator and 865 (22.5%) were identified as frail using the HFRS. Although agreement between the frailty instruments was fair (Kappa statistic = 0.322), each instrument classified different subgroups as frail. Both the Johns Hopkins ACG frailty indicator (rate ratio [RR], 1.13; 95% confidence interval [CI], 1.06 to 1.20) and the HFRS (RR, 1.14; 95% CI, 1.07 to 1.21) were significantly associated with increased one-year costs. Compared with the reference model, both the Johns Hopkins ACG frailty indicator and HFRS significantly improved NRI for one-year mortality (Johns Hopkins ACG frailty indicator: NRI, 0.160; P < 0.001; HFRS: NRI, 0.146; P = 0.001) and rehospitalization (Johns Hopkins ACG frailty indicator: NRI, 0.201; P < 0.001; HFRS: NRI, 0.141; P = 0.001). These improvements in NRI largely resulted from classification improvement among those who did not experience the event. With one-year mortality, there was a significant improvement in IDI (IDI, 0.003; P < 0.001) with the Johns Hopkins ACG frailty indicator. This improvement in performance resulted from an increase in the mean probability of the event among those with the event., Conclusion: Preoperative frailty assessment may add some predictive value for TAVI outcomes. Use of administrative database frailty instruments may provide small but significant improvements in case-mix adjustment when profiling hospitals for certain outcomes., (© 2022. Canadian Anesthesiologists' Society.)

Background: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency., Study Design: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups., Summary: The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV., Competing Interests: Declaration of competing interest Dr. Cornelis serves as a proctor for Boston Scientific. Dr. Cunnington has received fees for speaking at educational meetings from Medtronic and Abbott Vascular. Dr. Hildick-Smith is a proctor and advisor of Edwards Lifesciences, Medtronic, Abbott Vascular and Boston Scientific. Prof. Dr. Van Mieghem is a member of the advisory board of Abbot Vascular, Boston Scientific, Medtronic and a member of the scientific board of PulseCath B.V. The other authors have no conflict of interest to declare. Individual files with the ICMJE forms will be provided separately., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: The optimal strategy of monitoring for conduction disturbances in patients undergoing transcatheter aortic valve implantation (TAVI) is uncertain. We evaluated a pre- and post-TAVI remote ambulatory cardiac monitoring (rACM) strategy for identification of conduction disturbances and to reduce unplanned pre-discharge post-TAVI permanent pacemaker implantation (PPMI)., Methods and Results: REdireCT TAVI (NCT0381820) was a prospective cohort study of patients referred for outpatient TAVI. Patients with prior PPMI were excluded. Remote ambulatory cardiac monitoring consisted of 2 weeks of continuous electrocardiogram (ECG) monitoring (Pocket-ECGTM) both before and after TAVI. Compliance to monitoring, frequency of notifications, unplanned PPMI post-TAVI, and length of hospitalization were measured. Between June 2018 and March 2020, in 192 undergoing TAVI (mean age: 81.8 years; female sex 46%; balloon-expandable valve 95.3%), compliance to rACM was 91.7% pre-TAVI (mean duration: 12.8 days), and 87.5% post-TAVI (mean duration: 12.9 days). There were 24 (12.5%) rACM notifications (13 pre-TAVI; 11 post-TAVI) resulting in 14 (7.3%) planned PPMI: seven pre-TAVI [due to sinus pauses n = 2 or atrio-ventricular block (AVB) n = 5] and seven post-TAVI [due to sinus pauses n = 1 or AVB n = 5 or ventricular tachycardia (VT) n = 1]. In addition, nine (4.7%) patients received pre-TAVI PPMI due to high-risk baseline ECG (right bundle branch block with hemi-block or prolonged PR interval). Unplanned PPMI post-TAVI during index hospitalization occurred in six (3.1%) patients due to AVB and in one patient readmitted with AVB. The median length of stay post-TAVI was 1 day., Conclusion: A strategy of routine rACM was feasible and frequently led to PPMI. Our approach of 2-week rACM both pre- and post-TAVI achieves both high patient compliance and sufficient surveillance., Clinical Trial Registration: Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03810820., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The 3M-TAVR trial (3M-Transcatheter Aortic Valve Replacement) demonstrated the feasibility and safety of next-day hospital discharge after transfemoral TAVR with implementation of a minimalist pathway. However, the economic impact of this approach is unknown. Therefore, we evaluated costs for patients undergoing minimalist TAVR compared with conventional TAVR., Methods: We used propensity matching to compare resource utilization and costs (from a US health care system perspective) for patients in the 3M-TAVR trial with those for transfemoral TAVR patients enrolled in the contemporaneous S3i trial (PARTNER SAPIEN-3 Intermediate Risk). Procedural costs were estimated using measured resource utilization for both groups. For the S3i group, all other costs through 30-day follow-up were assessed by linkage with Medicare claims; for 3M, these costs were assessed using regression models derived from S3i cost and resource utilization data., Results: After 1:1 propensity matching, 351 pairs were included in our study (mean age 82, mean Society of Thoracic Surgery risk score 5.3%). There were no differences in death, stroke, or rehospitalization between the 3M-TAVR and S3i groups through 30-day follow-up. Index hospitalization costs were $10 843/patient lower in the 3M-TAVR cohort, driven by reductions in procedure duration, anesthesia costs, and length of stay. Between discharge and 30 days, costs were similar for the 2 groups such that cumulative 30-day costs were $11 305/patient lower in the 3M-TAVR cohort compared with the S3i cohort ($49 425 versus $60 729, 95% CI for difference $9378 to $13 138; P <0.001)., Conclusions: Compared with conventional transfemoral TAVR, use of a minimalist pathway in intermediate-risk patients was associated with similar clinical outcomes and substantial in-hospital cost savings, which were sustained through 30 days., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT02287662.

Bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF) may be caused by structural or nonstructural valve dysfunction. Both surgical and transcatheter bioprosthetic valves have limited durability because of structural valve deterioration. The main objective of this summary of experts participating in a virtual workshop was to propose standardized definitions for nonstructural and structural BVD and BVF following aortic or mitral biological valve replacement with the goal of facilitating research reporting and implementation of these terms in clinical practice. Definitions of structural BVF, based on valve reintervention or death, underestimate the true incidence of BVF. However, definitions solely based on the presence of high transprosthetic gradient at a given echocardiogram during follow-up overestimate the incidence of structural BVD and BVF. Definitions of aortic or mitral structural BVD must therefore include the confirmation by imaging of permanent structural changes to the leaflets alongside evidence of deterioration in valve hemodynamic function at echocardiography follow-up., Competing Interests: Funding Support and Author Disclosures Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and WL Gore; has received consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and has equity in Holistick Medical and Microinterventional Devices. Dr Hahn has received speaker fees from Abbott Structural, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic and Novartis; and has equity in Navigate. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Dweck has served as a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaking fees from NVT. Dr Leipsic has served as a consultant for Circle CVI and MVRX; and has received institutional funding for CT core laboratory analyses from Edwards Lifesciences, Neovasc, Abbott, Medtronic, Boston Scientific, PI Cardia, and Conformal. Dr Rogers has served as a consultant and physician proctor for Edwards Lifesciences and Medtronic; has served as an advisory board member for Medtronic; and holds equity interest in Transmural Systems. Dr Sathananthan has served as a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaking fees from NVT. Dr Guerrero has received institutional research grant support from Edwards Lifesciences. Dr Ternacle has served as a consultant for Philips Healthcare and Abbott Medical. Dr Barbanti has served as a consultant for Edwards Lifesciences and Boston Scientific. Dr Généreux has served as a consultant and advisor for and received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, and Medtronic; has served as a consultant for Boston Scientific, GE Healthcare, iRhythm Technologies, Opsens, Siemens, and Teleflex; has served as a consultant, PI Eclipse Trial, for Cardiovascular System Inc; has served as a consultant, advisor, and proctor for and received speaker fees and research grant from Edwards LifeSciences for the PI EARLY-TAVR and PI PROGRESS trials; has served as a consultant for and has equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; has served as a consultant for and received speaker fees from Shockwave; and has served as a consultant for the PI Feasibility study for 4C Medical. Dr Kaneko has served as a consultant for Edwards Lifesciences, Medtronic, and Abbott Structural. Dr Wood has served as a consultant to and his institution (CCI-CIC) receives grant support from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Gillam has served as a consultant to Philips and Bracco; is an advisory board member for Edwards Lifesciences; and has core lab contracts with Edwards Lifesciences, Medtronic, and Abbott for which she receives no direct compensation. Dr Reardon has served as a consultant for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical; all fees for such are to his department. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Thourani has performed consulting/research for Abbott Vascular, Boston Scientific, Cryolife, Edwards Lifesciences, Medtronic, and Shockwave. Dr Bax’s institution (Department of Cardiology, LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Mack has served as a co-principal investigator for clinical trials for Abbott and Edwards Lifesciences; and has served as study chair for a trial for Medtronic; all roles were uncompensated. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p <0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p <0.001) and septic shock (adjusted p <0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background Transcatheter aortic valve implantation (TAVI) is a minimally invasive therapy for patients with severe aortic stenosis, which has become standard of care. The objective of this study was to determine the maximum cost-effective investment in TAVI care that should be made at a health system level to meet quality indicator goals. Methods and Results We performed a cost-utility analysis using probabilistic patient-level simulation of TAVI care from the Ontario, Canada, Ministry of Health perspective. Costs and health utilities were accrued over a 2-year time horizon. We created 4 hypothetical strategies that represented TAVI care meeting ≥1 quality indicator targets, (1) reduced wait times, (2) reduced hospital length of stay, (3) reduced pacemaker use, and (4) combined strategy, and compared these with current TAVI care. Per-person costs, quality-adjusted life years, and clinical outcomes were estimated by the model. Using these, incremental net monetary benefits were calculated for each strategy at different cost-effectiveness thresholds between $0 and $100 000 per quality-adjusted life year. Clinical improvements over the current practice were estimated with all comparator strategies. In Ontario, achieving quality indicator benchmarks could avoid ≈26 wait-list deaths and 200 wait-list hospitalizations annually. Compared with current TAVI care, the incremental net monetary benefit for this strategy varied from $10 765 (±$8721) and $17 221 (±$8977). This would translate to an annual investment of between ≈$14 to ≈$22 million by the Ontario Ministry of Health to incentivize these performance measures being cost-effective. Conclusions This study has quantified the modest annual investment required and substantial clinical benefit of meeting improvement goals in TAVI care.

Objectives: To understand the patient and hospital level drivers of the variation in surgical versus trascatheter aortic valve replacement (SAVR vs TAVR) for patients with aortic stenosis (AS) and to explore whether this variation translates into differences in clinical outcomes., Background: Adoption of TAVR has grown exponentially worldwide. Notwithstanding, a wide variation in TAVR rates has been seen within and between countries and in some jurisdictions AS is still primarily being managed by SAVR., Methods: We conducted a population-based retrospective cohort study in Ontario, Canada, including individuals who received TAVR or SAVR between 2016 and 2020. We developed iterative hierarchical logistic regression models for the likelihood of receiving TAVR instead of SAVR examining sequentially patient characteristics, hospital factors and year of procedure, calculating the median ORs and variance partition coefficients for each. Using Cox proportional hazards models, we examined the relationship between TAVR/SAVR ratio on all-cause mortality and readmissions., Results: Annual procedures rates per million population increased from 171 to 201, mainly driven by the expansion of TAVR. TAVR/SAVR ratios differed substantially between hospitals, from 0.21 to 3.27. Neither patient nor hospital factors explained the between-hospital variation in AS treatment. The TAVR/SAVR ratio was significantly associated with clinical outcomes with high ratio hospitals having lower mortality and rehospitalisations., Conclusions: Despite the expansion of TAVR, dramatic variation exists that is not explained by patient or hospital factors. This variation was associated with differences in clinical outcomes, suggesting that further work is needed in understanding and addressing inequity of access., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: The economic value of transcatheter aortic valve replacement (TAVR) in low surgical risk patients with severe, symptomatic aortic stenosis is not known. Our objective was to determine the cost-effectiveness of balloon-expandable TAVR and self-expandable TAVR relative to surgical aortic valve replacement (SAVR) in low-risk patients., Methods and Results: A fully probabilistic Markov cohort model was constructed to estimate differences in costs and effectiveness [quality-adjusted life years (QALYs)] over the patient's life-time time from the third-party payer's perspective. Clinical outcomes modelled were alive/well (no complications), permanent stroke, ≥moderate paravalvular leak, new pacemaker, rehospitalization, and death. A network meta-analysis of the PARTNER 3 and Evolut Low Risk trial was performed to compare balloon-expandable TAVR, self-expandable TAVR, and SAVR for the efficacy inputs. Incremental-cost effectiveness ratios (ICER) were calculated. The total life-time costs in the balloon-expandable TAVR, self-expandable-TAVR, and SAVR arms were $37  330 ± 4724, $39 660 ± 4862, and $34 583 ± 6731, respectively, and total life-time QALYs gained were 9.15 ± 3.23, 9.13 ± 3.23, and 9.05 ± 3.20, respectively. The ICERs for balloon-expandable TAVR and self-expandable TAVR against SAVR were $27 196/QALY and $59 641/QALY, respectively. Balloon-expandable TAVR was less costly and more effective than self-expandable TAVR. There was substantial uncertainty, with 53% and 58% of model iterations showing balloon-expandable TAVR to be the preferred option at willingness-to-pay thresholds of $50 000/QALY and $100  000/QALY, respectively., Conclusion: Compared with SAVR, TAVR, particularly with balloon-expandable prostheses may be a cost-effective option for patients with severe aortic stenosis at low surgical risk., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background The treatment of aortic stenosis is evolving rapidly. Pace of change in the care of patients undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differs. We sought to determine differences in temporal changes in 30-day mortality, 30-day readmission, and length of stay after TAVR and SAVR. Methods and Results We conducted a retrospective cohort study of patients treated in the United States between 2012 and 2019 using data from the Medicare Data Set Analytic File 100% Fee for Service database. We included consecutive patients enrolled in Medicare Parts A and B and aged ≥65 years who had SAVR or transfemoral TAVR. We defined 3 study cohorts, including all SAVR, isolated SAVR (without concomitant procedures), and elective isolated SAVR and TAVR. The primary end point was 30-day mortality; secondary end points were 30-day readmission and length of stay. Statistical models controlled for patient demographics, frailty measured by the Hospital Frailty Risk Score, and comorbidities measured by the Elixhauser Comorbidity Index (ECI). Cox proportional hazard models were developed with TAVR versus SAVR as the main covariates with a 2-way interaction term with index year. We repeated these analyses restricted to full aortic valve replacement hospitals offering both SAVR and TAVR. The main study cohort included 245 269 patients with SAVR and 188 580 patients with TAVR, with mean±SD ages 74.3±6.0 years and 80.7±6.9 years, respectively, and 36.5% and 46.2% female patients, respectively. Patients with TAVR had higher ECI scores (6.4±3.6 versus 4.4±3) and were more frail (55.4% versus 33.5%). Total aortic valve replacement volumes increased 61% during the 7-year span; TAVR volumes surpassed SAVR in 2017. The magnitude of mortality benefit associated with TAVR increased until 2016 in the main cohort (2012: hazard ratio [HR], 0.76 [95% CI, 0.67-0.86]; 2016: HR, 0.39 [95% CI, 0.36-0.43]); although TAVR continued to have lower mortality rates from 2017 to 2019, the magnitude of benefit over SAVR was attenuated. A similar pattern was seen with readmission, with a lower risk of readmission from 2012 to 2016 for patients with TAVR (2012: HR, 0.68 [95% CI, 0.63-0.73]; 2016: HR, 0.43 [95% CI, 0.41-0.45]) followed by a lesser difference from 2017 to 2019. Year over year, TAVR was associated with increasingly shorter lengths of stay compared with SAVR (2012: HR, 1.91 [95% CI, 1.84-1.98]; 2019: HR, 5.34 [95% CI, 5.22-5.45]). These results were consistent in full aortic valve replacement hospitals. Conclusions The rate of improvement in TAVR outpaced SAVR until 2016, with the recent presence of U-shaped phenomena suggesting a narrowing gap between outcomes. Future longitudinal research is needed to determine the long-term implications of lowering risk profiles across treatment options to guide case selection and clinical care.

Background The multidisciplinary Heart Team (HT) is recommended for management decisions for transcatheter aortic valve replacement (TAVR) candidates, and during TAVR procedures. Empiric evidence to support these recommendations is limited. We aimed to explore temporal trends, drivers, and outcomes associated with HT utilization. Methods and Results TAVR candidates were identified in Ontario, Canada, from April 1, 2012 to March 31, 2019. The HT was defined as having a billing code for both a cardiologist and cardiac surgeon during the referral period. The procedural team was defined as a billing code during the TAVR procedure. Hierarchical logistical models were used to determine the drivers of HT. Median odds ratios were calculated to quantify the degree of variation among hospitals. Of 10 412 patients referred for TAVR consideration, 5489 (52.7%) patients underwent a HT during the referral period, with substantial range between hospitals (median odds ratio of 1.78). Utilization of a HT for TAVR referrals declined from 69.9% to 41.1% over the years of the study. Patient characteristics such as older age, frailty and dementia, and hospital characteristics including TAVR program size, were found associated with lower HT utilization. In TAVR procedures, the procedural team included both cardiologists and cardiac surgeons in 94.9% of cases, with minimal variation over time or between hospitals. Conclusions There has been substantial decline in HT utilization for TAVR candidates over time. In addition, maturity of TAVR programs was associated with lower HT utilization.

Herein, we describe the unique interplay among biomedical ethics, principles of distributive justice, and economic theory to highlight the role of health technology assessments to compare therapeutic options for aortic valve replacement. From the perspective of the Canadian health care system, transcatheter aortic-valve implantation is associated with higher costs but also higher incremental health benefits compared with surgical aortic-valve replacement. At current willingness to pay thresholds, transcatheter aortic-valve replacement is likely cost effective across the spectrum of risk, from inoperable patients to those at low surgical risk. However, we highlight the nuances within each subgroup of surgical risk that merit careful consideration by the heart team. Moreover, incorporation of patients and their preferences in decision-making is key. In particular, in young, low-risk patients, there remains uncertainty regarding the optimal treatment, with unique concerns around valve durability, selection of valve prosthesis, and consideration for special procedures such as the Ross procedure. Nonetheless, current research suggests that, universally, patients prefer a less invasive approach compared with a more invasive approach. Finally, we highlight that there remain critical issues around timeliness of access to care and unacceptable geographic inequities across Canada. Further research into alternative funding mechanisms and integrated cross-sector care pathways is necessary to address these issues., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Paucity of RCTs of non-drug technologies lead to widespread dependence on non-randomized studies. Relationship between nonrandomized study design attributes and biased estimates of treatment effects are poorly understood. Our purpose was to estimate the bias associated with specific nonrandomized study attributes among studies comparing transcatheter aortic valve implantation with surgical aortic valve replacement for the treatment of severe aortic stenosis., Results: We included 6 RCTs and 87 nonrandomized studies. Surgical risk scores were similar for comparison groups in RCTs, but were higher for patients having transcatheter aortic valve implantation in nonrandomized studies. Nonrandomized studies underestimated the benefit of transcatheter aortic valve implantation compared with RCTs. For example, nonrandomized studies without adjustment estimated a higher risk of postoperative mortality for transcatheter aortic valve implantation compared with surgical aortic valve replacement (OR 1.43 [95% CI 1.26 to 1.62]) than high quality RCTs (OR 0.78 [95% CI 0.54 to 1.11). Nonrandomized studies using propensity score matching (OR 1.13 [95% CI 0.85 to 1.52]) and regression modelling (OR 0.68 [95% CI 0.57 to 0.81]) to adjust results estimated treatment effects closer to high quality RCTs. Nonrandomized studies describing losses to follow-up estimated treatment effects that were significantly closer to high quality RCT than nonrandomized studies that did not., Conclusion: Studies with different attributes produce different estimates of treatment effects. Study design attributes related to the completeness of follow-up may explain biased treatment estimates in nonrandomized studies, as in the case of aortic valve replacement where high-risk patients were preferentially selected for the newer (transcatheter) procedure.

Background: Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk., Objectives: The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR., Methods: This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries., Results: Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk., Conclusions: STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes., Competing Interests: Funding Support and Author Disclosures Dr. Faroux has received fellowship support from Institut Servier and the Association Régionale de Cardiologie de Champagne-Ardenne (ARCCA); and has received research grants from Biotronik, Edwards Lifesciences, and Medtronic. Dr. Abdel-Wahab has served as a consultant for Boston Scientific and Medtronic. Dr. Windecker has received research and educational grants from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed. Dr. Auffret has received lecture fees from Edwards Lifesciences and Medtronic. Dr. Trillo-Nouche has served as a proctor for Boston Scientific and Medtronic. Dr. Toggweiler has served as a consultant and proctor for Abbott, Boston Scientific, Biosensors, and Medtronic. Dr. Tarantini has received lecture fees from Boston Scientific, Edwards Lifesciences, Gada, and Medtronic. Dr. Saia has served as a member of advisory boards for Abbott, Edwards Lifesciences, and Medtronic. Dr. Durand has served as a consultant for Edwards Lifesciences. Dr. Asmarats has served as a proctor for Abbott. Dr. Nejjari has served as a proctor for Abbott and Boston Scientific. Dr. Muntané-Carol was supported by a grant from the Fundación Alfonso Martín Escudero (Madrid, Spain). Dr. Mangieri has received an institutional grant from Boston Scientific. Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific; and holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has transformed severe aortic stenosis (AS) management. Our aim was understand AS cost drivers from referral to 1-year post-procedure., Methods and Results: We identified patients referred for either TAVR/SAVR between 1 April 2015 and 31 March 2018, with follow-up until 31 March 2019 in Ontario, Canada. We stratified costs into (i) a referral phase, (ii) a procedural phase from the procedure date to 60 days post-procedure, and (iii) post-procedure phase from 61 days to 1 year. Multivariable regression modelling using generalized linear models with a log link gamma distribution was used to identify cost drivers in each phase. The study cohort included 12 086 AS patients; 4832 were referred for TAVR and 7254 were referred for SAVR. The median cost for TAVR was higher than SAVR in the referral ($3593 vs. $2944) and post-procedural ($5938 vs. $3257) phases. In contrast, for the procedural phase, SAVR had a median cost of $29 756 vs. $27 907 for TAVR. Predictors of high cost in the referral phase were longer wait-time, and an urgent in-hospital procedure. In the procedural phase, procedural complications were the major drivers of higher cost. In the post-procedural phase, patient co-morbidities were the major drivers, specifically dialysis, liver disease, cancer, peripheral vascular disease, and diabetes mellitus., Conclusion: We identified distinct patterns of cost accumulation and modifiable drivers for SAVR compared with TAVR; these drivers may guide clinical and health policy decisions to make AS care more efficient., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Objectives: We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory., Background: Optimal fluoroscopic projections of aortic valve cusps have not been well described., Methods: A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated., Results: High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively., Conclusion: Distributions of each cusp's leaflet alignment follows "sigmoid curve" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt., (© 2020 Wiley Periodicals LLC.)

Background: Patients with severe, symptomatic aortic stenosis derive substantial 30-day quality of life (QOL) benefit from transcatheter aortic valve replacement (TAVR). Whether the QOL benefit of TAVR emerges earlier is unknown. We used data from the Multimodality, Multidisciplinary but Minimalist (3M) TAVR study to assess early changes in QOL after transfemoral (TF) TAVR., Methods: Health status was assessed at baseline, 2-weeks, 30-days, and 1-year after TAVR using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Medical Outcomes Study Short-Form 12 (SF-12). The KCCQ overall summary (KCCQ-OS) score (range 0-100; higher scores = better health) was the primary health status outcome. Linear mixed effects models were used to describe trajectories of QOL scores over time. A good outcome was defined as being "alive and well", with a KCCQ-OS score ≥ 60 points with no decrease from baseline ≥10 points., Results: A total of 358 patients (87.1%) completed the baseline and at least one follow-up survey. Between baseline and 2-weeks, the KCCQ-OS increased by 21.3 points (95% confidence interval [CI]: 19.3-23.2). This improvement was sustained over time with only slight further improvement between 2-weeks and 1-month (3.4 points; 95% CI: 1.4 to 5.5) and no significant change between 1-month and 1-year (1.9 points; 95% CI: -0.2 to 4.1). Scores for the KCCQ subscales and SF-12 physical and mental component summary scales showed a similar pattern. Most patients (74.4%) were "alive and well" at 2 weeks with similar rates at 1-month and 1-year (79.5% and 77.3%, respectively)., Conclusions: Among patients undergoing TF-TAVR, both disease-specific and generic health status improved substantially within the first 2 weeks, with only minimal further improvement thereafter., Competing Interests: Declaration of competing interest SBL: Consulting fees from Edwards LifeSciences and Abbott. JS: Consulting fees from Edwards LifeSciences. SJB: Research grant support from Boston Scientific Corp. Consulting fees from Abiomed and Boston Scientific Corp. RCW: Research grant support from Astra Zeneca, Bayer, Boehringer Ingelheim, and Pfizer. Personal honoraria from Astra Zeneca, Bayer, Boehringer Ingelheim, and Bristol Meyer Squibb/Pfizer. JLV: Research grant support and consulting fees from Edwards LifeSciences. JGW: Research grant support from Edwards LifeSciences, Abbott, Boston Scientific, Vivitro Medical. DAW: Research grant support from Edwards Life Sciences, Abbott. DJC: Research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; consulting fees from Edwards Lifesciences, Medtronic, Abbott Vascular and Boston Scientific. The other authors report no conflicts., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) has emerged as a reasonable alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis (AS). There is limited data on temporal trends in wait-times and access to care for patients with AS, irrespective of treatment modality. We sought to investigate the trends in wait-times for the treatment (either SAVR or TAVR) of AS in Ontario, Canada, and to understand the drivers of wait-list mortality and hospitalization due to heart failure., Methods: In this population-level retrospective cohort study, we identified patients from April 1, 2012, to March 31, 2018, who were referred for treatment of symptomatic severe AS awaiting either SAVR or TAVR. The primary outcome was the median total wait-time from referral date to either SAVR or TAVR procedure. Primary clinical outcomes were all-cause mortality and heart failure-related hospitalizations while on the wait-list., Results: The referral cohort consisted of a total of 22 876 referrals for aortic valve replacement, with (N=8098) TAVR and (N=14 778) SAVR referrals. The mean and median wait times for the overall AVR cohort were 87 and 59 days, respectively. The TAVR subcohort had longer wait-times (median 84 days) compared with the SAVR subcohort (median 50 days). Year over year, there was a statistically significant an increase in wait-times ( P <0.001) for the overall AS cohort as well as each of the TAVR ( P <0.0001) and SAVR ( P <0.0001) subgroups. Wait-time mortality was 2.5% (TAVR 5.2% and SAVR 1.05%), while the cumulative probability of heart failure hospitalization was 3.6% (TAVR 7.7% and SAVR 1.3%)., Conclusions: In patients with severe symptomatic AS awaiting aortic valve replacement, there has been a trend of increasing wait times for both SAVR and TAVR. This was associated with increasing mortality and hospitalizations related to heart failure while on the wait-list.

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.)

Background: Rehospitalization rates post-transcatheter aortic valve replacement (TAVR) are high; however, it is not known how these compare with pre-TAVR hospitalization rates. Our objective was to determine the association between the index TAVR and hospitalization rates pre- and postprocedure., Methods: A retrospective observational study was performed including all TAVR procedures performed in Ontario, Canada, between 2013 and 2017. Patients who died during the index hospitalization were excluded. The primary outcome was all-cause hospitalization within 1 year of TAVR discharge. Hospitalization rates per person-year were calculated and compared for each of the following analogous time periods pre- and post-index TAVR: 1 to 30, 31 to 90, 91 to 365, and 1 to 365 days. Poisson regression models were used to generate rate ratios to compare hospitalization rates., Results: The final study cohort included 2547 patients. In the year before TAVR, 60.2% of patients were hospitalized, compared with 45.9% in the year following the procedure. The rate ratio (RR) for the year post-TAVR compared with pre-TAVR was 0.82 (95% confidence interval [CI], 0.77- 0.88). When comparing each parallel time period post- vs pre-TAVR, all intervals were associated with significant reductions in hospitalization after TAVR, except the 30-day periprocedural period. The largest change in hospitalization rates occurred in the 31 to 90 days post- vs the corresponding period pre-TAVR (RR: 0.57; 95% CI, 0.50-0.64) CONCLUSION: TAVR is associated with a significant and sustained reduction in all-cause hospitalization in the year following the procedure compared with the preprocedural period., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: There is wide variation in hospitalization costs for transcatheter aortic valve replacement (TAVR), suggesting inefficiency in care delivery. Our goal was to identify drivers of health care costs in TAVR., Methods: Demographics, procedural details, in-hospital complications, and costs for all adults undergoing first-time TAVR from 2012 to 2016 in Ontario, Canada, were obtained through linkages of clinical/administrative databases. Total costs included were from initial referral to the first of either death or 1-year post-TAVR. Phase-based costing was performed to empirically estimate the presence, duration, and cost per patient for each phase up to 1 year or death. Multivariable regression was used to identify drivers of cost accumulation per phase., Results: We identified 2009 first-time TAVR patients (mean age 81.7 ± 7.6, 45.9% female and Society of Thoracic Surgeons (STS) score of 7.2 ± 5.8). Phases of cost were identified with an early high-cost period within 60 days of referral, a second phase from the procedure to 60 days, and a stable phase from 60 to 360 days postprocedure. The referral phase median cost was $4527 (interquartile range [IQR]: 1708-12,594), the procedure to 60 days phase median cost was $29,518 (IQR: 24,842-40,279), and the post 60-day stable phase median cost was $6053 (IQR: 3320-17,048). Predictors of higher cost in the referral phase were in-hospital wait location, dialysis dependence, and heart-failure status. In the second (procedural) phase, predictors were nontransfemoral access, complications of stroke, and pacemaker insertion. Predictors of higher cost in the third (stable) phase were predominantly nonmodifiable, such as frailty., Conclusions: This analysis shows that there are 3 distinct phases of cost accumulation from referral to post-TAVR with some potentially modifiable cost drivers in each phase., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Aims: Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV., Methods and Results: A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2-12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02-1.13)], age [HR 1.21 (95% CI 1.01-1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11-1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis-patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31-14.39)], device malposition [SHR 3.75 (95% CI 1.36-10.35)], EBEV [SHR 3.34 (95% CI 1.26-8.85)], and age [SHR 0.59 (95% CI 0.44-0.78)]., Conclusions: The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Recent clinical trial results showed that transcatheter aortic valve replacement (TAVR) is noninferior and may be superior to surgical aortic valve replacement (SAVR) for mortality, stroke, and rehospitalization. However, the impact of transcatheter valve durability remains uncertain., Methods: Discrete event simulation was used to model hypothetical scenarios of TAVR versus SAVR durability in which TAVR failure times were varied to determine the impact of TAVR valve durability on life expectancy in a cohort of low-risk patients similar to those in recent trials. Discrete event simulation modeling was used to estimate the tradeoff between a less invasive procedure with unknown valve durability (TAVR) and that of a more invasive procedure with known durability (SAVR). Standardized differences were calculated, and a difference >0.10 was considered clinically significant. In the base-case analysis, patients with structural valve deterioration requiring reoperation were assumed to undergo a valve-in-valve TAVR procedure. A sensitivity analysis was conducted to determine the impact of TAVR valve durability on life expectancy in younger age groups (40, 50, and 60 years)., Results: Our cohort consisted of patients with aortic stenosis at low surgical risk with a mean age of 73.4±5.9 years. In the base-case scenario, the standardized difference in life expectancy was <0.10 between TAVR and SAVR until transcatheter valve prosthesis failure time was 70% shorter than that of surgical prostheses. At a transcatheter valve failure time <30% compared with surgical valves, SAVR was the preferred option. In younger patients, life expectancy was reduced when TAVR durability was 30%, 40%, and 50% shorter than that of surgical valves in 40-, 50-, and 60-year-old patients, respectively., Conclusions: According to our simulation models, the durability of TAVR valves must be 70% shorter than that of surgical valves to result in reduced life expectancy in patients with demographics similar to those of recent trials. However, in younger patients, this threshold for TAVR valve durability was substantially higher. These findings suggest that durability concerns should not influence the initial treatment decision concerning TAVR versus SAVR in older low-risk patients on the basis of current evidence supporting TAVR valve durability. However, in younger low-risk patients, valve durability must be weighed against other patient factors such as life expectancy.

Background: There has been an exponential increase in the demand for transcatheter aortic valve replacement (TAVR). Our goal was to examine trends in TAVR capacity and wait-times across Canada., Methods: All TAVR cases were identified from April 1, 2014, to March 31, 2017. Wait-time was defined as the duration in days from the initial referral to the TAVR procedure. TAVR capacity was defined as the number of TAVR procedures per million population/province/fiscal year. We performed multivariable multilevel Cox proportional hazards modelling of the time to TAVR as the dependant variable and the effect of provinces as random effects. We quantified the variation in wait-times among provinces using the median hazard ratio., Results: We identified a total of 4906 TAVR procedures across 9 provinces. Despite a year over year increase in overall capacity, there was a greater than 3-fold difference in capacity between provinces. Crude median wait-times increased over time in all provinces, with marked variation from 71.5 days in Newfoundland to 190.5 and 203 days in Manitoba and Alberta, respectively. This suggests increasing demand outpaced the growth in capacity. We found a median hazard ratio of 1.62, indicating that in half of the possible pairwise comparisons, the time to TAVR for identical patients was at least 62% longer between different provinces., Conclusion: We found substantial geographic inequity in TAVR access. This calls for policy makers, clinicians, and administrators across Canada to address this inequity through revaluation of provincial funding mechanisms, as well as implementation of efficient care pathways., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: There has been rapid growth in the demand for transcatheter aortic valve replacement (TAVR), which has the potential to overwhelm current capacity. This imbalance between demand and capacity may lead to prolonged wait times, and subsequent adverse outcomes while patients are on the waitlist. We sought to understand the relationship between regional differences in capacity, TAVR wait times and morbidity/mortality on the waitlist., Methods and Results: We modelled the effect of TAVR capacity, defined as the number of TAVR procedures per million residents/region, on the hazard of having a TAVR in Ontario from April 2012 to March 2017. Our primary outcome was the time from referral to a TAVR procedure or other off-list reasons on the waitlist/end of the observation period as measured in days. Clinical outcomes of interest were all-cause mortality, all-cause hospitalisations or heart failure-related hospitalisations while on the waitlist for TAVR. There was an almost fourfold difference in TAVR capacity across the 14 regions in Ontario, ranging from 31.5 to 119.5 TAVR procedures per million residents. The relationship between TAVR capacity and wait times was complex and non-linear. In general, increased capacity was associated with shorter wait times (p<0.001), reduced mortality (HR 0.94; p=0.08) and all-cause hospitalisations (p=0.009)., Conclusions: The results of the present study have important policy implications, suggesting that there is a need to improve TAVR capacity, as well as develop wait-time strategies to triage patients, in order to decrease wait times and mitigate the hazard of adverse patient outcomes while on the waitlist., Competing Interests: Competing interests: NF is a consultant for Edwards Life Sciences., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: When transcatheter aortic valve replacement (TAVR) was first approved by the Food and Drug Administration in October 2011, it was an innovative treatment with limited accessibility. However, over the past few years, TAVR has become standard of care in patients with aortic stenosis. The effect of socioeconomic status (SES) on this transition of use of TAVR is unknown., Method: Using the New York state department Statewide Planning and Research Cooperative System database, we compared baseline patient characteristics and facilities in low-income areas and high-income areas. Trends in residential SES of patients undergoing TAVR were examined over time and assessed with a Poisson regression and Cochran Armitage trend tests., Result: From October 2011 and 2012 to December 2016, we found that the numbers of TAVR procedures performed among patients from both low (187-1150 in 2016, P < .001) and high (227-1160, P < .001) income areas increased over time. The proportion of TAVR procedures performed in patients from low-income areas increased over time, while those in high-income areas decreased (from 45.2% in 2011 and 2012 to 49.8% in 2016 for low-income and from 54.8%-50.2% for high-income, P = .009)., Conclusion: In the case of TAVR in New York State, when the innovative treatment was introduced in the clinical practice, there were initial SES-based disparities in access to the procedure. However, these disparities resolved over time, probably due to the broader diffusion of the technique., (© 2019 Wiley Periodicals, Inc.)

Transcatheter aortic valve implantation (TAVI) or replacement has rapidly changed the treatment of patients with severe symptomatic aortic stenosis. It is now the standard of care for patients believed to be inoperable or at high surgical risk, and a reasonable alternative to surgical aortic valve replacement for those at intermediate surgical risk. Recent clinical trial data have shown the benefits of this technology in patients at low surgical risk as well. This update of the 2012 Canadian Cardiovascular Society TAVI position statement incorporates clinical evidence to provide a practical framework for patient selection that does not rely on surgical risk scores but rather on individual patient evaluation of risk and benefit from either TAVI or surgical aortic valve replacement. In addition, this statement features new wait time categories and treatment time goals for patients accepted for TAVI. Institutional requirements and recommendations for operator training and maintenance of competency have also been revised to reflect current standards. Procedural considerations such as decision-making for concomitant coronary intervention, antiplatelet therapy after intervention, and follow-up guidelines are also discussed. Finally, we suggest that all patients with aortic stenosis might benefit from evaluation by the heart team to determine the optimal individualized treatment decision., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: No data exist about the characteristics of infective endocarditis (IE) post-transcatheter aortic valve replacement (TAVR) according to transcatheter valve type. We aimed to determine the incidence, clinical characteristics, and outcomes of patients with IE post-TAVR treated with balloon-expandable valve (BEV) versus self-expanding valve (SEV) systems., Methods: Data from the multicenter Infectious Endocarditis After TAVR International Registry was used to compare IE patients with BEV versus SEV., Results: A total of 245 patients with IE post-TAVR were included (SEV, 47%; BEV, 53%). The timing between TAVR and IE was similar between groups (SEV, 5.5 [1.2-15] months versus BEV, 5.3 [1.7-11.4] months; P =0.89). Enterococcal IE was more frequent in the SEV group (36.5% versus 15.4%; P <0.01), and vegetation location differed according to valve type (stent frame, SEV, 18.6%; BEV, 6.9%; P =0.01; valve leaflet, SEV, 23.9%; BEV, 38.5%; P =0.01). BEV recipients had a higher rate of stroke/systemic embolism (20.0% versus 8.7%, adjusted OR: 2.46, 95% CI: 1.04-5.82, P =0.04). Surgical explant of the transcatheter valve (SEV, 8.7%; BEV, 13.8%; P =0.21), and in-hospital death at the time of IE episode (SEV, 35.6%; BEV, 37.7%; P =0.74) were similar between groups. After a mean follow-up of 13±12 months, 59.1% and 54.6% of the SEV and BEV recipients, respectively, had died ( P =0.66)., Conclusions: The characteristics of IE post-TAVR, including microorganism type, vegetation location, and embolic complications but not early or late mortality, differed according to valve type. These results may help to guide the diagnosis and management of IE and inform future research studies in the field.

Background Transcatheter aortic valve replacement (TAVR) is the standard of care for many patients with severe symptomatic aortic stenosis and relies on accurate sizing of the aortic annulus. It has been suggested that 3-dimensional transesophageal echocardiography (3D TEE) may be used instead of multidetector computed tomography (MDCT) for TAVR planning. This systematic review and meta-analysis compared 3D TEE and MDCT for pre-TAVR measurements. Methods and Results A systematic literature search was performed. The primary outcome was the correlation coefficient between 3D TEE- and MDCT-measured annular area. Secondary outcomes were correlation coefficients for mean annular diameter, annular perimeter, and left ventricular outflow tract area; interobserver and intraobserver agreements; mean differences between 3D TEE and MDCT measurements; and pooled sensitivities, specificities, and receiver operating characteristic area under curve values of 3D TEE and MDCT for discriminating post-TAVR paravalvular aortic regurgitation. A random effects model was used. Meta-regression and leave-one-out analysis for the primary outcome were performed. Nineteen studies with a total of 1599 patients were included. Correlations between 3D TEE and MDCT annular area, annular perimeter, annular diameter, and left ventricular outflow tract area measurements were strong (0.86 [95% CI, 0.80-0.90]; 0.89 [CI, 0.82-0.93]; 0.80 [CI, 0.70-0.87]; and 0.78 [CI, 0.61-0.88], respectively). Mean differences between 3D TEE and MDCT between measurements were small and nonsignificant. Interobserver and intraobserver agreement and discriminatory abilities for paravalvular aortic regurgitation were good for both 3D TEE and MDCT. Conclusions For pre-TAVR planning, 3D TEE is comparable to MDCT. In patients with renal dysfunction, 3D TEE may be potentially advantageous for TAVR measurements because of the lack of contrast exposure.

Background: While most self-expanding transcatheter valves are repositionable, only one fully retrievable valve is currently available. The Meridian valve is a new self-expanding valve with full retrievability properties. The objective of our study was to evaluate the early feasibility, preliminary safety, and efficacy of transcatheter aortic valve replacement with the HLT Meridian valve (HLT, Inc)., Methods: This was a multicenter early feasibility study including patients with severe aortic stenosis at high surgical risk undergoing transfemoral transcatheter aortic valve replacement with the 25-mm Meridian valve. All serious adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiography data were assessed by an independent echocardiography core laboratory., Results: A total of 25 patients (mean age, 85±6 years; 80% of men) were included. The valve was successfully implanted in 22 (88%) patients (annulus too large and extreme horizontal aorta in 2 and 1 unsuccessful cases, respectively). Valve retrieval because of an initial nonadequate positioning was attempted and successfully performed in 10 (40%) patients. Echocardiography post-transcatheter aortic valve replacement showed a low mean residual gradient (10±4 mm Hg) and the absence of moderate-severe aortic regurgitation (none-trace and mild aortic regurgitation in 76% and 24% of patients, respectively). Mortality at 30 days was 8%, with no cases of disabling stroke, valve embolization, or major/life-threatening bleeding complications. At 6-month follow-up, the cumulative mortality rate was 12%, with no changes in echocardiographic parameters and no cases of valve dysfunction. The majority of patients (89%) were in New York Heart Association class I-II at 6 months., Conclusions: Transcatheter aortic valve replacement with the Meridian valve was feasible and associated with acceptable early and 6-month clinical results. Valve retrieval after full valve deployment was successfully performed in all attempted cases, and valve performance was excellent, with low residual gradients, no cases of moderate-severe aortic regurgitation, and none-trace residual aortic regurgitation in the majority of patients., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02838680 (RADIANT-Canada); NCT02799823 (RADIANT-US).

Background: Studies have shown that patients who undergo trans-catheter aortic valve replacement (TAVR) have high rates of hospital readmission. Our objectives were to identify the causes of readmission after TAVR, determine whether transitional care factors were associated with a reduction in readmission and to identify other predictors that could be used to target quality improvement efforts., Methods: We conducted a chart abstraction study that included all patients who underwent TAVR in Ontario, Canada between 2007 and 2013 and survived to hospital discharge. These data were linked to provincial administrative databases. The association between transitional care factors (home care, rehabilitation, family physician and cardiologist follow-up) and 1-year hospital readmission was examined using a time-to-event analysis. Cause-specific hazards models were used to account for the competing risk of death., Results: There were 937 patients in the cohort and the rate of readmission at 1-year was 49%. The most common causes of readmission were heart failure and bleeding. Rehabilitation (HR 1.34, 95% CI 1.11-1.62; p = 0.002) and cardiologist follow-up (HR 1.41, 95% CI 1.14-1.75; p = 0.002) were both associated with higher readmission rates. While, home care (HR 1.18, 95% CI 0.96-1.44; p = 0.12) and family physician follow-up (HR 1.04, 95% CI 0.85-1.28; p = 0.71) were not associated with readmission., Conclusion: Readmission post TAVR is common; however, we did not identify any transitional care factors associated with reductions in hospital readmission. This suggests ongoing research is required to identify targets for improvement in post-procedural care.

Background Rapid growth in transcatheter aortic valve replacement ( TAVR ) demand has translated to inadequate access, reflected by prolonged wait times. Increasing wait times are associated with important adverse outcomes while on the wait-list; however, it is unknown if prolonged wait times influence postprocedural outcomes. Our objective was to determine the association between TAVR wait times and postprocedural outcomes. Methods and Results In this population-based study in Ontario, Canada, we identified all TAVR procedures between April 1, 2010, and March 31, 2016. Wait time was defined as the number of days between initial referral and the procedure. Primary outcomes of interest were 30-day all-cause mortality and all-cause readmission. Multivariable regression models incorporated wait time as a nonlinear variable, using cubic splines. The study cohort included 2170 TAVR procedures, of which 1741 cases were elective and 429 were urgent. There was a significant, nonlinear relationship between TAVR wait time and post- TAVR 30-day mortality, as well as 30-day readmission. We observed an increased hazard associated with shorter wait times that diminished as wait times increased. This statistically significant nonlinear relationship was seen in the unadjusted model as well as after adjusting for clinical variables. However, after adjusting for case urgency status, there was no relationship between wait times and postprocedural outcomes. In sensitivity analyses restricted to either only elective or only urgent cases, there was no relationship between wait times and postprocedural outcomes. Conclusions Wait time has a complex relationship with postprocedural outcomes that is mediated entirely by urgency status. This suggests that further research should elucidate factors that predict hospitalization requiring urgent TAVR while on the wait list.

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.)