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Background: Although aortic valve replacement is associated with a major benefit in high-gradient (HG) severe aortic stenosis (AS), the results in low-gradient (LG, mean gradient <40 mm Hg) AS are conflicting. LG severe AS may be subdivided in classical low-flow (left ventricular ejection fraction <50%) and LG (CLF-LG); paradoxical low-flow (left ventricular ejection fraction ≥50% but stroke volume index <35 mL/m 2 ) and LG; and normal-flow (left ventricular ejection fraction ≥50% and stroke volume index ≥35 mL/m 2 ) and LG. The primary objective is to determine in the PARTNER 2 trial (The Placement of Aortic Transcatheter Valves) and registry the outcomes after aortic valve replacement of the 4 flow-gradient groups., Methods: A total of 3511 patients from the PARTNER 2 Cohort A randomized trial (n=1910) and SAPIEN 3 registry (n=1601) were included. The flow-gradient pattern was determined at baseline transthoracic echocardiography and classified as follows: (1) HG; (2) CLF-LG; (3) paradoxical low-flow-LG; and (4) normal-flow-LG. The primary end point for this analysis was the composite of (1) death; (2) rehospitalization for heart failure symptoms and valve prosthesis complication; or (3) stroke., Results: The distribution was HG, 2229 patients (63.5%); CLF-LG, 689 patients (19.6%); paradoxical low-flow-LG, 247 patients (7.0%); and normal-flow-LG, 346 patients (9.9%). The 2-year rate of primary end point was higher in CLF-LG (38.8%) versus HG: 31.8% ( P =0.002) and normal-flow-LG: 32.1% ( P =0.05) but was not statistically different from paradoxical low-flow-LG: 33.6% ( P =0.18). There was no significant difference in the 2-year rates of clinical events between transcatheter aortic valve replacement versus surgical aortic valve replacement in the whole cohort and within each flow-gradient group., Conclusions: The LG AS pattern was highly prevalent (36.5%) in the PARTNER 2 trial and registry. CLF-LG was the most common pattern of LG AS and was associated with higher rates of death, rehospitalization, or stroke at 2 years compared with the HG group. Clinical outcomes were as good in the LG AS groups with preserved left ventricular ejection fraction compared with the HG group.

Background: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR)., Methods: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories., Results: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P =0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P <0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P =0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm 2 ; P =0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P =0.30). Valvulo-arterial impedance (Z va ), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m 2 ; P <0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Z va and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year., Conclusions: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Z va and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

Objectives: To demonstrate safety, feasibility and short-term clinical outcomes after transcatheter aortic valve-in-valve (ViV) implantation under local anesthesia without contrast aortography or echocardiographic guidance., Background: Transcatheter ViV implantation is an emerging treatment modality for patients with degenerative surgical bioprostheses. Given the radiopaque properties of the surgical aortic valve (SAV) frame, ViV procedures can often be performed with fluoroscopic guidance alone., Methods: ViV implantation was performed in 37 patients with SAV failure under local anesthesia without contrast aortography. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days., Results: Mean age was 74 ± 10 years and STS predicted risk of mortality was 5.6 ± 2.4%. Mean transaortic gradient decreased from 39.4 ± 15.5 mmHg to 13 ± 6.3 mmHg at discharge (p < .001), and 20 ± 7.5 mmHg at 30 days (p < .001 compared to baseline), aortic valve area increased from 0.9 ± 0.3 cm 2 to 1.2 ± 0.4 cm 2 at 30 days (p = .007). No patient had more than mild aortic regurgitation. Hospital discharge occurred at a median of 2.6 ± 4.4 days. At 30-day follow-up there were no deaths, myocardial infarctions, strokes, repeat hospital admissions for heart failure, or renal failure. One patient (2.7%) required a new pacemaker. 93% of the patients were in New York Heart Association functional class I or II., Conclusions: Transcatheter aortic ViV implantation for selected patients with degenerative surgical bioprostheses under local anesthesia without aortography or echocardiographic guidance is feasible and safe., (© 2019 Wiley Periodicals, Inc.)

Background: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk., Methods: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population., Results: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation., Conclusions: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)., (Copyright © 2019 Massachusetts Medical Society.)

Amid rapid growth in transcatheter valvular interventions computed tomography (CT) has emerged as a pivotal noninvasive imaging resource that can be used throughout many stages of the transcatheter heart valve process, enhancing procedural success and efficacy. It affords a three-dimensional assessment of the aortic and challenging saddle-shaped mitral annulus, facilitating appropriate device selection, sizing, and preprocedural prediction angles for prosthetic deployment. Postprocedural imaging allows documentation of procedural success, evaluation of prosthesis positioning, and identifying asymptomatic complications. This article provides an overview of the role of CT in both trancatheter aortic valve repair (TAVR) and transcatheter mitral valve replacement (TMVR)., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The success and continued rapid clinical integration of transcatheter valve technologies relies on imaging modalities to guide safe and effective device deployment. In particular, cardiac imaging, using both echocardiography and CT, is an integral resource for the multidisciplinary team. These modalities can provide valuable insight for the proceduralist at each stage of transcatheter-based valve insertion, as they can be used reliably to define the anatomy of interest and its relationship to surrounding structures, determine accurate device sizing, assess patients for valve-in-valve procedures, and screen for adverse features or procedural contraindications. We provide an overview of some of the key aspects of the use of CT and echocardiography in the context of transcatheter aortic valve replacement (TAVR), as well as transcatheter mitral valve replacement (TMVR).

Background: After transcatheter aortic valve implantation, early leaflet thickening, presumably reflecting thrombus, has recently been described on computed tomography angiography (CTA) in ~10% of the patients. We sought to investigate the impact of the antithrombotic regimen on the course of leaflet thickening., Methods: The study comprised 51 patients with leaflet thickening. Based on the time period, patients without an established indication for anticoagulation were put on phenprocoumon plus clopidogrel for at least 3 months or on dual antiplatelet therapy with aspirin and clopidogrel. Follow-up CTAs were evaluated for leaflet restriction, assessed by four-point-grading score, and maximal thickness., Findings: The anticoagulation and the dual antiplatelet therapy group comprised 29 and 22 patients, respectively. After a median of 86 days, we obtained follow-up CTAs in 22 patients on anticoagulation and in 16 patients on dual antiplatelet therapy. Leaflet thickening progressed in 11 on dual antiplatelet therapy, but always regressed onanticoagulation. The course of leaflet restriction and maximal thickness was significantly different between the two groups (P < 0.001): in the dual antiplatelet therapy group, maximal thickness increased by a mean of 1.37 ± 1.67 mm (P = 0.005) and leaflet restriction score by a median 1[quartiles 0;2] (P = 0.013), whereas in the anticoagulation group, maximal thickness regressed by 2.57 ± 1.52 mm (P < 0.001) and leaflet restriction score decreased by 1[-4;0] (P = 0.001). After a median of 91 days after discontinuation of anticoagulation, CTA performed in ten patients revealed a significant recurrent increase in leaflet restriction score and maximal thickness (P = 0.023, P = 0.007). In the entire cohort, changes in leaflet restriction correlated significantly with changes in transvalvular pressure gradients (r = 0.511, P < 0.001)., Interpretation: The course of leaflet restriction was fundamentally different depending on the presence or absence of anticoagulation, with consistent regression under phenprocoumon, but mostly progression under antiplatelet therapy alone. Changes in leaflet restriction were associated with changes in transvalvular pressure gradients.

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.)

The treatment of both aortic and now mitral valvular disease has been transformed through transcatheter valvular interventions. TAVR has rapidly become the treatment of choice for symptomatic severe aortic stenosis in both high, and now intermediate-risk patients. Building upon this success the last two years have seen the clinical introduction of transcatheter mitral valve replacement (TMVR), with a number of devices being utilised in first-in-man and feasibility studies. These experiences have helped determine the anatomical requirements and specifications that enable successful device deployment and avoidance of complications. A unique strength of cardiac CT is the ability to identify and characterise calcification of the aortic and mitral apparatus, en-abling a deeper understanding of the relationship of calcification and procedural complications.

Background: Motion correction (MC) algorithms have been shown to improve image quality, interpretability and diagnostic accuracy in coronary CT angiography. We sought to determine whether MC extended to the whole heart would demonstrate improved image quality and reproducibility of aortic annular measurements in pre-TAVR CT., Materials and Methods: Twenty-two consecutive contrast enhanced CT data sets acquired for pre TAVR evaluation using retrospective ECG synchronization during a single heart beat were retrospectively identified. Image data sets were obtained from raw data acquired at 35% and 75% of the R-R interval using both standard (STD) and motion corrected (MC) reconstruction algorithms. Four data sets (2 STD, 2 MC) per patient were analyzed by 2 independent, blinded readers for aortic annular area, short and long axis, perimeter and average diameter. Image quality was graded using a 5 point Likert score (1 and 2 non diagnostic, 5 excellent). Statistical analysis was performed using Wilcoxon matched paired tests, Bland-Altman (B-A) plots and Lin's concordance coefficient comparing 35% STD to 35% MC, and 75% STD to 75% MC., Results: Eighty-eight datasets were analyzed (44 STD, 44 MC). At 35%, there was a significant improvement in image quality for MC (Likert score 3.3 ± 0.9 STD vs. 3.9 ± 0.7 MC, p < 0.007). While B-A analysis demonstrated narrower interobserver agreement for aortic annular area (bias 0.03 vs 0.02 cm(2), range -0.32 to 0.39 cm(2) vs -0.50 to 0.55 cm(2)), and perimeter (bias 0.3 vs 0.3 mm, range -3.1 to 3.8 mm vs -4.6 to 5.3 mm), this was not statistically significant by concordance correlation coefficient. At 75%, there was no significant difference in image quality (Likert score 3.3 ± 0.9 vs. 3.5 ± 0.76, p = 0.454) or annular measurement agreement intervals., Conclusion: Motion correction algorithms may yield significant improvements of image quality in systolic CT data sets of the heart. Further validation studies are required to determine the effect on annular measurements and translation into clinical practice., (Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

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

Transcatheter aortic valve replacement (TAVR) has become the standard of care for patients with hemodynamically severe aortic stenosis who are symptomatic but deemed too high risk for surgery. Recent reports suggest that sex differences exist in outcomes following TAVR and in the diagnostic imaging evaluation of patients being considered for TAVR. In this review, the authors explore the differences between men and women in baseline characteristics and outcomes following TAVR, as well as sex differences in the imaging findings of severe aortic stenosis (AS) including the diagnostic challenges in the hemodynamic assessment of severe AS in elderly women, differences in aortic valvular calcification and in the associated myocardial response to severe AS. Additionally, sex differences in imaging findings as they relate to post-TAVR complications including coronary obstruction, annular rupture and prosthesis-patient mismatch are also discussed., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Aortic annulus rupture is a rare, but potentially fatal complication of transcatheter aortic valve replacement (TAVR), especially when it occurs by balloon-expandable devices. In order to improve the predictability of procedures and avoid ruptures we investigated whether or not the aortic root volume measures is a useful indicator of risk, and if it could be useful for the prosthesis size selection., Methods and Results: From a retrospective series of 172 TAVR patients, seven experienced contained aortic annulus ruptures. The receiver operating curves were used to illustrate sensitivity and specificity of the different aortic annulus size and aortic root volume measures. The annulus area oversizing of ≥20% resulted in a sensitivity of 100%, specificity of 55.76%, and positive predictive value (PPV) of 8.75%. In patients receiving 26 mm prostheses, the aortic root volume (ARV <13600 mm(3)) provided a better specificity and PPV (79.63 and 18.52%, respectively). A two-step testing procedure considering the area derived average annulus diameter (Darea <23 mm) as a first separating parameter and then the ARV (<13,600 mm(3)) as a further indicator showed the most promising results with the PPV of 31.25%. Regardless of the procedure steps no false negative results were predicted., Conclusions: Our data show that the ARV provides a better predictive value for correct prosthesis sizing than established annulus measurements, especially in 'borderline' annuli. We suggest a two-step testing procedure for prostheses size selection, considering Darea and ARV to minimize the risk of annulus rupture. Prospective studies and examination of larger datasets are warranted to confirm these findings., (© 2015 Wiley Periodicals, Inc.)

Objectives: We report our 8-year experience in transcatheter aortic and mitral valve-in-valve (VinV) implantation., Background: Feasibility and good early outcomes associated with transcatheter aortic and mitral VinV implantation into failed surgical bioprostheses have been confirmed, but the mid-term and long-term outcomes of transcatheter aortic and mitral VinV is unknown., Methods: A total of 73 patients with aortic (n = 42) and mitral (n = 31) bioprosthetic valve dysfunction underwent transcatheter VinV implantation between April 2007 and December 2013. Edwards balloon-expandable transcatheter valves (Edwards Lifesciences Inc., Irvine, California) were used. Median follow-up was 2.52 years with a maximum of 8 years., Results: Seventy-two patients (mean age 79.7 ± 9.4 years, 32 women) underwent successful VinV implantation (success rate 98.6%). At 30 days, all-cause mortality was 1.4%, disabling stroke 1.4%, life-threatening bleeding 4.1%, acute kidney injury requiring hemodialysis 2.7%, and coronary artery obstruction requiring intervention 1.4%. No patient had greater than mild paravalvular leak. Estimated survival rates were 88.9%, 79.5%, 69.8%, 61.9%, and 40.5% at 1, 2, 3, 4, and 5 years, respectively. The small surgical valve size (19 and 21 mm) was an independent risk factor for reduced survival in aortic VinV patients. At 2-year follow-up, 82.8% of aortic and 100% of mitral VinV patients were in New York Heart Association functional class I or II., Conclusions: Transcatheter VinV for failed surgical bioprostheses can be performed safely with a high success rate and minimal early mortality and morbidity. Transcatheter VinV provides encouraging mid-term clinical outcomes in this high-risk elderly cohort of patients. Transcatheter VinV is an acceptable alternative therapy for failed aortic or mitral bioprostheses in selected high-risk patients., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Little is known about how "Heart Team" treatment decisions among patients suitable for either surgical aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI) are made under routine conditions., Methods and Results: The "Heart Team" decision-making process was analysed with respect to124 patients of a non-randomised prospective clinical trial that included patients aged ≥75 years: 41 patients underwent AVR and 83 underwent TAVI. By use of the non-parametric classification and regression tree (CART) methodology, 21 baseline parameters were tested to reconstruct the decision process retrospectively. Next, multivariate logistic and Cox regression models were fitted to evaluate the decision and outcome relevance (two-year survival) of the parameters as identified in the CART procedure. For patients with a baseline EuroSCORE I ≥13.48%, no further cut-off points were identified and the majority of these patients underwent TAVI. Among patients with a baseline EuroSCORE I <13.48%, age and left ventricular ejection fraction (LVEF) were identified as further relevant decision parameters. The decision relevance of EuroSCORE I (p=0.003), age (p=0.024) and LVEF (p=0.047) were confirmed by multivariate analysis; however, outcome relevance can be confirmed for EuroSCORE I (p=0.015) only, while treatment decision (TAVI or AVR) was not a significant predictor of mortality (p=0.655)., Conclusions: Despite or even because of the systematic risk selection according to EuroSCORE I values, we observed two-year survival rates of about 75% regardless of whether the patient received TAVI or AVR, suggesting that the decisions made by the "Heart Team" were appropriate.

Objectives: The aim of this study was to evaluate a strategy of intentional underexpansion of excessively oversized balloon-expandable transcatheter heart valves (THVs) in terms of clinical outcomes, valve function, and frame durability at 1 year., Background: Transcatheter aortic valve replacement requires the selection of an optimally sized THV to ensure paravalvular sealing and fixation without risking annular injury. However, some patients have "borderline" annular dimensions that require choosing between a THV that may be too small or another that may be too large., Methods: We evaluated 47 patients at risk of annular injury who underwent transcatheter aortic valve replacement (TAVR) with an oversized, but deliberately underexpanded, THV followed by post-dilation if required. Clinical evaluation, echocardiography, and cardiac computed tomography were performed pre-TAVR, post-TAVR, and at 1 year., Results: Deployment of oversized THVs with modest underfilling of the deployment balloon (<10% by volume) was not associated with significant annular injury. Paravalvular regurgitation was mild or less in 95.7% of patients, with post-dilation required in 10.7%. THV hemodynamic function was excellent and remained stable at 1 year. Computed tomography documented stent frame circularity in 87.5%. Underexpansion was greatest within the intra-annular THV inflow (stent frame area 85.8% of nominal). There was no evidence of stent frame recoil, deformation, or fracture at 1 year., Conclusions: In carefully selected patients with borderline annulus dimensions and in whom excessive oversizing of a balloon-expandable SAPIEN XT valve (Edwards Lifesciences, Inc., Irvine, California) is a concern, a strategy of deliberate underexpansion, with ad hoc post-dilation, if necessary, may reduce the risk of annular injury without compromising valve performance., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform., Background: The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known., Methods: Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography., Results: Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR., Conclusions: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In transcatheter aortic valve replacement, prosthesis oversizing is essential to prevent paravalvular regurgitation. However, the estimated extent of oversizing strongly depends on the measurement used for annular sizing., Purpose: The aim was to investigate the influence of geometrical parameters for calculation of relative oversizing in transcatheter aortic valve replacement, reported as percentage in relation to the native annulus size, to standardize reporting., Methods: Electrocardiogram-gated cardiac dual-source CT data of 130 consecutive patients with severe aortic stenosis (mean age, 81 ± 8 years; 56 men; mean aortic valve area, 0.67 ± 0.18 cm2) were included. Aortic annulus dimensions were quantified by means of planimetry that yielded area and perimeter at the level of the basal attachment points of the aortic cusps during systole. Area- and perimeter-derived diameters were calculated as DA = 2 × √(A/π) and DP = P/π. Hypothetical prosthesis sizing was based on DA (23-mm prosthesis for 19-22 mm; 26-mm prosthesis for 22-25 mm; 29-mm prosthesis for 25-28 mm). Relative oversizing for hypothetical prosthesis selection was calculated as percentage in relation to the native annulus size., Results: Mean annulus area was 492.12 ± 94.9 mm2 and mean perimeter was 80.1 ± 7.6 mm. DP was significantly larger than DA (25.5 ± 2.4 mm vs 24.9 ± 2.4 mm; P < .001). Mean maximum diameter was 28.1 ± 3.0 mm and mean minimal diameter was 22.8 ± 2.4 mm. Calculated eccentricity index [EI = 1 - minimal diameter/maximum diameter)] was 0.19 ± 0.06. Difference between DP and DA correlated significantly with EI (r = 0.67; P < .001). Relative oversizing was 10.2% ± 3.8% and 21.6% ± 8.4% by DA and area, and 7.8% ± 3.9% by both DP and perimeter., Conclusion: For planimetric assessment of aortic annulus dimensions with CT, the percentage oversizing calculated strongly depends on the geometrical variable used for quantifying annular dimensions. Standardized nomenclature seems warranted for comparison of future studies., (Copyright © 2014 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement is a new method to treat patients with symptomatic, severe aortic stenosis who are at high surgical risk. Short- and midterm results have been encouraging, with more than 90,000 procedures performed worldwide. Patient selection, prosthesis sizing, and access strategies heavily rely on noninvasive imaging. Computed tomographic (CT) angiography is increasingly used for peri-interventional evaluation, as this modality allows for objective three-dimensional assessment of the aortic root, evaluation of the iliofemoral access route, and prediction of appropriate projection angles for prosthesis deployment. Compared with two-dimensional imaging techniques, CT provides comprehensive information about aortic annulus anatomy and geometry, supporting appropriate patient selection and prosthesis sizing. Recently, integration of CT measurements into sizing algorithms has been demonstrated to significantly reduce the incidence of paravalvular regurgitation, compared with prosthesis sizing with two-dimensional echocardiography. In addition, CT-based vascular access planning has been shown to reduce vascular access complications. Postprocedural CT imaging allows for the documentation of procedural success, evaluation of prosthesis positioning, and identification of asymptomatic complications. In this article, the rapidly emerging role of CT in the context of transcatheter aortic valve replacement will be described. Online supplemental material is available for this article., (© RSNA, 2013.)

Background: Prosthesis-patient mismatch (PPM) is a predictor of mortality after aortic valve replacement (AVR)., Objective: We examined whether accurate 3-dimensional annular sizing with multidetector CT (MDCT) is predictive of PPM after transcatheter AVR (TAVR)., Methods: One hundred twenty-eight patients underwent MDCT then TAVR. Moderate PPM was defined as an indexed effective orifice area ≤0.85 cm²/m² and severe ≤0.65 cm²/m². MDCT annular measurements (area, short and long axis) were compared with the size of the selected transcatheter heart valve (THV) to obtain (1) the difference between prosthesis size and CT-measured mean annular diameter and (2) the percentage of undersizing or oversizing (calculated as 100 × [MDCT annular area--THV nominal area]/THV nominal area). In addition, the MDCT annular area was indexed to body surface area. These measures were evaluated as potential PPM predictors., Results: We found that 42.2% of patients had moderate PPM and 9.4% had severe PPM. Procedural characteristics and in-hospital outcomes were similar between patients with or without PPM. THV undersizing of the mean aortic annulus diameter was not predictive of PPM (odds ratio [OR], 0.84; 95% CI, 0.65-1.07; P = .16; area under the receiver-operating characteristic curve [AUC], 0.58). THV undersizing of annular area was not predictive of PPM (OR, 0.96; 95% CI, 0.80-1.16; P = .69; AUC, 0.52). Indexed MDCT annular area was, however, predictive of PPM (OR, 0.24; 95% CI, 0.10-0.59; P < .001; AUC, 0.66)., Conclusions: PPM is frequent after TAVR. Appropriate annular oversizing does not reduce the rate or severity of PPM. Patient annulus size mismatch, identified by indexed MDCT annular area, is a significant predictor of PPM., (Copyright © 2013 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate pulsatile changes of the aortic annulus and their impact on prosthesis selection by computed tomography (CT)., Background: Precise noninvasive prosthesis sizing is a prerequisite for transcatheter aortic valve replacement., Methods: A total of 110 patients with severe aortic stenosis (mean age: 82.9 ± 8 years, mean aortic valve area: 0.69 ± 0.18 cm(2)) underwent electrocardiogram-gated CT. Aortic annulus dimensions were planimetrically quantified as area-derived diameter (D(A) = 2 ×✓(CSA/π), where CSA is the cross-sectional area) and perimeter-derived diameter (D(P) = P/π, where P is the length of the perimeter) in 5% increments of the RR interval. Hypothetical prosthesis sizing was based on D(A) and D(P) (23-mm prosthesis for <22 mm; 26 mm: 22 to 25 mm; 29 mm: >25 mm) and compared between maximum and traditional cardiac CT reconstruction phases at 35% and 75% of RR. Agreement for prosthesis selection was calculated by κ statistics., Results: D(A) and D(P) were increased and eccentricity was reduced during systole, with D(A-MAX) and D(P-MAX) most often observed at 20% of RR. D(P) was consistently larger than D(A). Average net differences were 2.0 ± 0.6 mm and 1.7 ± 0.5 mm by D(A-MIN) versus D(A-MAX) and D(P-MIN) versus D(P-MAX). Agreement for prosthesis sizing was found in 93 of 110 patients (κ = 0.75) by D(A-75%) and in 80 of 110 patients (κ = 0.53) by D(A-MAX) compared with D(A-35%); and in 94 of 110 patients (κ = 0.73) by D(P-75%) and in 93 of 110 patients (κ = 0.73) by D(P-MAX) compared with D(P-35%). With sizing by D(A-75%) or D(P-75%), nominal prosthesis diameter was smaller than D(A-MAX) or D(P-MAX) in 15 and 6 patients respectively., Conclusions: Aortic annulus morphology exhibits conformational pulsatile changes throughout the cardiac cycle due to deformation and stretch. These changes affect prosthesis selection. Prosthesis selection by diastolic perimeter- or area-derived dimensions harbors the risk of undersizing., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of our study was to investigate the feasibility, image quality, and clinical implications of a combined dual-source CT angiography (CTA) protocol to assess aortic root anatomy and aortoiliac vasculature in patients with severe aortic stenosis evaluated for transcatheter aortic valve implantation., Subjects and Methods: Eighty consecutive patients (47 women and 33 men; mean age, 82.3 ± 7.8 [SD] years) with severe aortic stenosis evaluated for transcatheter aortic valve implantation underwent a combined single-dose contrast-enhanced dual-source CTA protocol (body weight < 70 kg, 110 mL of contrast medium; ≥ 70 kg, 130 mL) consisting of ECG-gated dual-source CTA of the chest with integrated cardiac CT and ungated CTA of the abdomen and pelvis. Two independent observers measured the dimensions of the aortic root and the aortoiliac vasculature and rated image quality semiquantitatively. Vessel attenuation was assessed. Amenability to transfemoral access was evaluated on the basis of vessel diameter (> 7 mm), anatomy, and the presence of vascular disease., Results: Image quality of the aortic root was diagnostic in all 80 patients, and image quality of the aortoiliac vasculature was diagnostic in 79 patients. Vascular attenuation was greater than 200 HU at any vessel level. The mean diameter of the aortic annulus was 24.1 ± 2.9 (SD) mm. Inter- and intraobserver correlations for aortic root and aortoiliac measurements were high (r = 0.93-0.99). Aortic root dimensions were suitable for transcatheter aortic valve implantation in 65 patients (81%). Thirty-eight patients (48%) were deemed amenable to instant transfemoral access without another vasculature intervention., Conclusion: The dimensions of the aortic root and the aortoiliac vasculature can be assessed with a combined single-dose contrast-enhanced dual-source CTA protocol, thereby allowing determination of patient eligibility for transcatheter aortic valve implantation, prosthesis sizing, and evaluation of the access route in one examination.

Background: Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear.Objectives: The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement.Methods: A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year.Results: At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses.Conclusions: The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283). [ABSTRACT FROM AUTHOR]

Aims: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.Methods and Results: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.Conclusions: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies. [ABSTRACT FROM AUTHOR]