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Background: Insights into quantitative differences between core laboratory and center-reported echocardiographic assessment of the native and bioprosthetic aortic valve are lacking. We aimed to explore clinically relevant differences between these evaluations., Methods: Data were used from the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial for the Avalus valve. In this trial, patients with an indication for surgical aortic valve replacement (SAVR) due to aortic stenosis or regurgitation (AR) were enrolled. Serial echocardiographic examinations were performed at each center and blindly reanalyzed by an independent echocardiographic core laboratory (ECL). For the bioprosthetic valve analysis, postoperative data throughout the 5-year follow-up were pooled. Differences between the ECL and the centers in continuous parameters were quantified in mean differences and intraclass correlation coefficients (ICCs). Agreement on AR, paravalvular leak (PVL), and prosthesis-patient mismatch (PPM) classification was investigated using Cohen's kappa coefficients., Results: The analysis on the native aortic valve was performed on 1118 echocardiograms. The relative mean difference was largest for the left ventricular outflow tract (LVOT) area, followed by stroke volume and effective orifice area (index), with center-reported values being 11%-7% higher. High ICCs of around 0.90 were observed for the parameters peak aortic jet velocity, mean pressure gradient, and the velocity-time integral across the aortic valve. Over 5000 echocardiograms were available for the bioprosthetic valve analysis. Therein, comparable results were observed. The kappa coefficient was 0.59 (95% confidence interval [CI] 0.56, 0.63) for agreement on native AR, 0.28 (95% CI 0.18, 0.37) for PVL, and 0.42 (95% CI 0.40, 0.44) for PPM., Conclusions: There is high agreement between the ECL and clinical centers on continuous-wave Doppler-related measurements. In contrast, agreement is low for parameters that involve measurement of the LVOT diameter. These results provide important context for the interpretation of aortic valve performance in studies that lack central ECL evaluation., Trial Registration: ClinicalTrials.gov identifier: NCT02088554., (© 2024 The Author(s). Echocardiography published by Wiley Periodicals LLC.)

Aims: Aortic valve area (AVA) used for echocardiographic assessment of aortic stenosis (AS) has been traditionally interpreted independently of sex, age and race. As differences in normal values might impact clinical decision-making, we aimed to establish sex-, age- and race-specific normative values for AVA and Doppler parameters using data from the World Alliance Societies of Echocardiography (WASE) Study., Methods and Results: Two-dimensional transthoracic echocardiographic studies were obtained from 1903 healthy adult subjects (48% women). Measurements of the left ventricular outflow tract (LVOT) diameter and Doppler parameters, including AV and LVOT velocity time integrals (VTIs), AV mean pressure gradient, peak velocity, were obtained according to ASE/EACVI guidelines. AVA was calculated using the continuity equation. Compared with men, women had smaller LVOT diameters and AVA values, and higher AV peak velocities and mean gradients (all P < 0.05). LVOT and AV VTI were significantly higher in women (P < 0.05), and both parameters increased with age in both sexes. AVA differences persisted after indexing to body surface area. According to the current diagnostic criteria, 13.5% of women would have been considered to have mild AS and 1.4% moderate AS. LVOT diameter and AVA were lower in older subjects, both men and women, and were lower in Asians, compared with whites and blacks., Conclusion: WASE data provide clinically relevant information about significant differences in normal AVA and Doppler parameters according to sex, age, and race. The implementation of this information into clinical practice should involve development of specific normative values for each ethnic group using standardized methodology., Competing Interests: Conflict of interest: M.S., M.B. and N.H. are employees of TOMTEC Imaging Systems. No other direct conflicts of Interest related to this study have been reported by any of the authors., (© 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.)

This International Consensus Classification and Nomenclature for the congenital bicuspid aortic valve condition recognizes 3 types of bicuspid valves: 1. The fused type (right-left cusp fusion, right-non-coronary cusp fusion and left-non-coronary cusp fusion phenotypes); 2. The 2-sinus type (latero-lateral and antero-posterior phenotypes); and 3. The partial-fusion (forme fruste) type. The presence of raphe and the symmetry of the fused type phenotypes are critical aspects to describe. The International Consensus also recognizes 3 types of bicuspid valve-associated aortopathy: 1. The ascending phenotype; 2. The root phenotype; and 3. Extended phenotypes., (Copyright © 2021. Published by Elsevier Inc.)

This International evidence-based nomenclature and classification consensus on the congenital bicuspid aortic valve and its aortopathy recognizes 3 types of bicuspid aortic valve: 1. Fused type, with 3 phenotypes: right-left cusp fusion, right-non cusp fusion and left-non cusp fusion; 2. 2-sinus type with 2 phenotypes: Latero-lateral and antero-posterior; and 3. Partial-fusion or forme fruste. This consensus recognizes 3 bicuspid-aortopathy types: 1. Ascending phenotype; root phenotype; and 3. extended phenotypes., (Copyright © 2021. Published by Elsevier Inc.)

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.

Objectives: This study sought to evaluate the association between severity of left ventricular hypertrophy (LVH) before transcatheter aortic valve replacement (TAVR) and outcomes out to 5 years., Background: Prior studies assessing the association between baseline LVH and outcomes after surgical or TAVR for aortic stenosis (AS) have yielded conflicting results., Methods: Patients with severe symptomatic AS at intermediate or high risk in the PARTNER (Placement of Aortic Transcatheter Valve) 1, 2, and S3 trials and registries who received TAVR and had baseline measurements for left ventricular mass index (LVMi) were analyzed. The presence and severity of LVH was determined by LVMi using American Society of Echocardiography sex-specific cutoffs., Results: Among 4,280 patients, those with no (n = 1,325), mild (n = 777), moderate (n = 628), and severe (n = 1,550) LVH had 5-year rates of death of 32.8%, 37.3%, 37.2%, and 44.8%, respectively (p < 0.001), and 5-year rates of cardiovascular (CV) death or rehospitalization of 33.6%, 39.2%, 42.4%, and 49.2%, respectively (p < 0.001). After adjustment, severe LVH (compared with no LVH) was associated with increased all-cause death (adjusted hazard ratio: 1.16; 95% confidence interval: 1.00 to 1.34; p = 0.04) and CV death or rehospitalization (adjusted hazard ratio: 1.34; 95% confidence interval: 1.16 to 1.54; p < 0.001), but no increased hazard was observed for mild or moderate LVH. In spline analyses performed in males and females separately, there was a consistent linear association between increased LVMi and an increased adjusted hazard of CV mortality or rehospitalization. A similar relationship was observed for all-cause death in females, but not males., Conclusions: Severe baseline LVH is associated with higher 5-year death and rehospitalization rates after TAVR. These findings may have implications for the optimal timing of valve replacement and the potential role for medical therapy to slow or prevent LVH as AS progresses before valve replacement, but further studies are needed., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS)., Background: TAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials., Methods: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration-approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory., Results: Sixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days., Conclusions: TAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events., (Copyright © 2020. Published by Elsevier Inc.)

We sought to assess the impact of diastolic dysfunction (DD) grade, as per the 2016 American Society of Echocardiography/European Association of Cardiovascular Imaging guidelines, on survival of patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI). We included consecutive patients with severe AS who underwent TAVI in our institution. DD grading was determined retrospectively according to the 2016 ASE DD guidelines and categorized to grade I-III and indeterminate grade I-II DD. Comparison of 1-year survival according to DD grade was performed by Kaplan-Meier analysis, and evaluation of DD at 1 year was performed in a subset of patients. Among 606 TAVI patients, 394 (65%) had sufficient data for DD grading. Seventy-seven (20%) had grade I DD, 191 (48%) had grade II, 60 (15%) had grade III, and 66 (17%) had an indeterminate grade between I and II. Baseline characteristics indicate higher rates of atrial fibrillation, brain natriuretic peptide level, pulmonary artery systolic pressure, and indexed left ventricular mass as DD grade increases (all p ≤0.01). In conclusion, comparison of 1-year survival revealed a higher rate of mortality in patients with grade III DD that remained statistically significant following adjustment in a multivariate Cox proportional hazard model. DD grade after TAVI improved in patients with grades II and III. Severe AS patients with grade III DD have higher risk for 1-year mortality after TAVI compared with milder degrees of DD. Further research is warranted to explore a potential benefit for aortic valve therapy at an earlier stage of the disease process., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: This analysis evaluated echocardiographic predictors of hypoattenuated leaflet thickening (HALT) in low-risk patients undergoing transcatheter aortic valve replacement and assessed 1-year clinical and hemodynamic consequences. HALT by computed tomography may be associated with early valve degeneration and increased neurological events., Methods: Echocardiograms were performed at baseline, discharge, 30 days, and 1 year post-procedure. Four-dimensional contrast-enhanced computed tomography assessed HALT at 30 days. Independent core laboratories analyzed images. Doppler hemodynamic parameters were tested in a univariable regression model to identify HALT predictors. One-year clinical and hemodynamic outcomes were compared between HALT (+) and (-) patients., Results: Analysis included 170 patients with Sapien 3 valves and diagnostic 30-day computed tomographies, of whom 27 (16%) had HALT. Baseline characteristics were similar between groups. After transcatheter aortic valve replacement, aortic flow was nonsignificantly reduced in patients who developed HALT. Regression analysis did not show significant association between baseline or discharge valve hemodynamics and development of HALT at 30 days. Patients with HALT had smaller aortic valve areas (1.4±0.4 versus 1.7±0.5 cm 2 ; P =0.018) and Doppler velocity index (0.4±0.1 versus 0.5±0.1; P =0.003) than those without HALT at 30 days but not at 1 year. There was no difference in aortic mean gradient at 30 days. There was no difference between the groups in New York Heart Association class, 6-minute walk distance, and mortality at 1 year., Conclusions: There were no early hemodynamic predictors of HALT. At 30 days, patients with HALT had worse valve hemodynamics than those without HALT, but hemodynamic and clinical outcomes at 1 year were similar., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628899.

Objectives: The aim of this study was to determine the prognostic value of contractile reserve (CR) at baseline in patients with low-flow, low-gradient severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR)., Background: Patients with severe AS, left ventricular dysfunction, and low transaortic gradient are at high risk for mortality during surgical aortic valve replacement (SAVR). Furthermore, patients without CR have been shown to have perioperative mortality comparable to that of patients treated medically for severe AS., Methods: We retrospectively analyzed patients who underwent TAVR with a diagnosis of low-gradient severe AS (mean transvalvular aortic gradient < 40 mmHg, LVEF < 50%, and AVA ≤ 1.0 cm 2 or AVAi ≤ 0.6 cm 2 ) and who had a pre-TAVR dobutamine stress echocardiogram (DSE). Patients were stratified by the presence or absence of CR, defined as an increase in stroke volume ≥ 20% during DSE., Results: From 2008 to 2016, 61 patients with low-gradient severe AS underwent TAVR and had pre-TAVR DSE. CR was present in 31 patients (51%) and absent in 30 (49%). There was no significant difference between the two groups in baseline demographics, medical history, access site, or types of valves. All-cause mortality was similar in both groups at 30 days (13% with CR vs 10% without CR, P = 1.00) and 1 year (29% with CR vs 33% without CR, HR 1.20, 95% CI 0.49-2.96, P = 0.69)., Conclusion: In patients with low-flow, low-gradient severe AS undergoing TAVR, the presence or absence of CR does not predict all-cause mortality at 30 days or 1 year., (© 2018 Wiley Periodicals, Inc.)

Objectives: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve., Methods: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration-specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis., Results: The primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P < .0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P < .0001)., Conclusions: This analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Unicuspid aortic valve (UAV) is a rare disorder, often difficult to distinguish from bicuspid aortic valve (BAV). BAV and UAV share valve pathology such as the presence of a raphe, leaflet fusion, aortic stenosis, aortic regurgitation, and/or ascending aortic dilatation, but a comprehensive echocardiographic comparison of patients with UAV and BAV has not been previously performed., Methods: We investigated UAV and BAV patients at an early stage of disease included in GenTAC, a national registry of genetically related aortic aneurysms and associated cardiac conditions. Clinical and echocardiographic data from the GenTAC Registry were compared between 17 patients with UAV and 17 matched-controls with BAV., Results: Baseline characteristics including demographics, clinical findings including family history of BAV and aortic aneurysm/coarctation, and echocardiographic variables were similar between BAV and UAV patients; aortic stenosis was more common and more severe in patients with UAV. This was evidenced by higher mean and peak gradient, smaller aortic valve area, and more advanced valvular degeneration (all P < .05). There were no significant differences in aortic dimensions, with a similar pattern of enlargement of the ascending aorta., Conclusions: The similar baseline characteristics with more accelerated aortic valve degeneration and stenosis suggest that UAV represents an extreme in the spectrum of BAV syndromes. Therefore, it is reasonable to consider application of recommendations for the management of patients with BAV to those with the rarer UAV., (© 2017 Wiley Periodicals, Inc.)

This study analyzed the impact of sex, hemodynamic profile, and valve fusion pattern on aortopathy associated with bicuspid aortic valve (BAV). The National Heart Lung and Blood Institute-sponsored National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) provided comprehensive information on a large population of well-characterized patients with BAV. Of 969 enrolled patients with BAV, 551 (57%, 77% male) had already undergone valvular and/or aortic surgery. Echocardiographic imaging data were available on 339 unoperated or preoperative participants who formed the basis of this study. BAV function was normal in 45 (14%), with a predominant aortic regurgitation (AR) in 127 (41%) and a predominant aortic stenosis (AS) in 76 (22%). Moderate-severe AR was associated with larger sinus of Valsalva (SOV) diameters compared with normal function and AS (all p <0.01). Moderate-severe AS was associated with a larger ascending aortic (AscAo) diameter compared with normal function (p = 0.003) but not with AR. The SOV diameter was larger in men than in women (3.7 ± 0.7 vs 3.3 ± 0.6 cm, p <0.0001), whereas AscAo diameters were comparable (3.9 ± 0.9 vs 3.7 ± 0.9 cm, p = 0.08). Right-left commissural fusion was associated with a larger SOV diameter (3.7 ± 0.7 vs 3.3 ± 0.6 cm, p <0.0001) compared with a right-noncoronary fusion pattern. Predominant AR was more common in men (45% vs 27%, p = 0.004), whereas AS was more common in women (29% vs 18%, p = 0.04). In conclusion, in the GenTAC Registry, AR was associated with diffuse (annular, SOV, and AscAo) enlargement, whereas moderate-severe AS was only associated with AscAo enlargement. Male sex and right-left cusp pattern of cusp fusion were associated with larger SOV diameters and a greater likelihood of AR, whereas women had a higher prevalence of AS., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Subclinical leaflet thrombosis was recently described in a randomized trial of transcatheter aortic valve replacement. It was subsequently demonstrated in a series of registries that this was a commonly observed imaging finding seen in all transcatheter and surgical bioprostheses. The phenomenon has aroused considerable interest due to the as-yet-undefined risk for later clinical events and the possibility of pharmacological intervention with anticoagulation. Subclinical leaflet thrombosis is easily detected noninvasively by technically suitable computed tomography (CT) with a high degree of concordance to transesophageal echocardiography findings. The CT hallmarks were noted to be hypoattenuated leaflet thickening (HALT) associated with reduced leaflet motion (RELM). The combination of HALT and RELM signified hypoattenuation affecting motion, the standardized imaging endpoint used. This paper describes the systematic CT evaluation methodology that was devised during the Portico trial investigation and U.S. Food and Drug Administration submission; it also highlights the need for an ongoing discussion among experts to enable, with the help of the Valve Academic Research Consortium, standardization of reporting of this imaging finding to cater to the present and future needs of clinical trials., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There is no clear consensus in regard to the optimal anesthesia utilization during transcatheter aortic valve replacement (TAVR). The aim was to compare outcomes of transfemoral (TF) TAVR under monitored anesthesia care (MAC) vs. general anesthesia (GA) and evaluate the rates and causes of intra-procedural MAC failure., Methods: All consecutive patients who underwent TF TAVR from April 2007 through March 2015 were retrospectively analyzed and dichotomized into two groups: TAVR under MAC vs. GA. The main endpoints of the study included 30-day and 1-year mortality, the rates and reasons for failure of MAC, in-hospital clinical safety outcomes, and post-procedural hospital and intensive care unit length-of-stays., Results: A total of 533 patients (51% male, mean-age 83years) underwent TF TAVR under MAC (n=467) or GA (n=66). Fifty-six patients (12%) in the MAC group required conversion to GA. The MAC group had significantly shorter post-procedural hospital (6.0 vs. 7.9, p=0.023) and numerically shorter ICU (2.4 vs. 2.8, p=0.355) mean length-of-stays in days. The clinical safety outcomes were similar in both groups. Kaplan-Meier unadjusted cumulative in-hospital and 30-day mortality rates were higher in the GA group but similar in both groups at 1-year., Conclusions: TF TAVR under MAC is feasible and safe, results in shorter hospital stays, can be performed in the majority of cases, and should be utilized as the default strategy. Trans-esophageal echocardiography utilization during TAVR with MAC is safe and feasible. The most common cause for conversion of MAC to GA is cardiac instability and hypotension. The complete heart team should be available at all times in case the need arises for a rapid conversion to GA., (Copyright © 2016. Published by Elsevier Inc.)

Background: A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation., Methods: We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs])., Results: Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P=0.01 in the clinical trial; and 0% and 29%, respectively, P=0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P=0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P=0.007)., Conclusions: Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation. (Funded by St. Jude Medical and Cedars-Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.).

Aims: Transcatheter aortic valve therapy has become an established procedure for patients at high risk for surgical valve replacement. The BIOVALVE-I study aims to assess the safety and performance of a novel self-expanding transcatheter heart valve., Methods and Results: In this prospective, single-centre, first-in-human study, 13 patients with severe aortic stenosis suitable for transfemoral transcatheter aortic valve implantation were enrolled. Mean logistic EuroSCORE was 14.4±3.7% and mean STS PROM score was 4.3±1.6%. The primary endpoint, 30-day early safety composite per VARC-2, was observed in two patients (15.4%, one life-threatening bleeding and one valve-in-valve procedure). The implant was aborted in two patients due to unsuitable aortic anatomy. Overall, device success was obtained in nine patients (69.2%, two aborted implants, one valve-in-valve procedure and one patient with moderate aortic regurgitation). As determined by an independent core laboratory, all but one patient had less than moderate total aortic regurgitation at 30-day follow-up, mean aortic gradient was 6.7±2.3 mmHg and effective orifice area 1.8±0.3 cm. Pacemakers were implanted in three patients (23.1%), and no death, stroke, myocardial infarction or acute kidney failure was observed., Conclusions: In this first-in-human study, the feasibility of implantation of the BIOVALVE system and its re-sheathing functionality was demonstrated, and short-term safety data were encouraging. Larger studies are required to confirm the performance of the device.

Objective: Sutureless valves are designed to facilitate surgical implantation, including less-invasive techniques in aortic valve replacement, by maintaining surgical precision of implantation compared with transcatheter techniques. Long-term clinical experience with sutureless valves is lacking. We report the 5-year follow-up results of an international, prospective, multicenter study evaluating the clinical performance and safety of the 3f Enable valve (Medtronic Inc, Minneapolis, Minn)., Methods: Between March 2007 and December 2009, 141 patients (54 male; mean age, 76.1±5.7 years) undergoing aortic valve replacement with the 3f Enable valve were enrolled in 10 European sites. The mean follow-up was 2.76 years (range, 2 days to 5.1 years; total, 388.7 patient-years). Echocardiographic valvular hemodynamic and morphologic analyses were performed by an independent core laboratory., Results: The mean systolic gradient was 10.4±4.4 mm Hg at discharge and 7.7±4.1 mm Hg at 5 years. The mean effective orifice area was 1.7±0.5 cm2 at discharge and 1.6±0.2 cm2 at 5 years. Freedom from all-cause and valve-related mortality was 87.6%±2.9% and 96.8%±1.6% at 1 year (113 patients at risk) and 77.0%±7.5% and 93.8%±4.8% at 5 years (24 patients at risk), respectively. Six patients underwent reoperation (4 because of major paravalvular leakage and 2 because of endocarditis). Freedom from reoperation was 95.4%±1.9% at 1 year and 95.4%±6.1% at 5 years. No structural valve deterioration occurred during the follow-up period., Conclusions: The sutureless 3f Enable valve represents a safe and effective treatment for aortic valve stenosis, providing an excellent hemodynamic profile. This study represents the longest follow-up study for a sutureless bioprosthesis. Sutureless valves may become an option for all patients with indicated biological aortic valve replacement., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The Mitroflow valve (Sorin Group, Milan, Italy) has been in use since 1982 and has shown long-term durability in large studies from European centers but has not been studied for long-term hemodynamics in large standardized multicenter trials. This study sought to assess the hemodynamics of the Mitroflow valve by extending the duration of follow-up in an ongoing prospective multicenter trial conducted in North America., Methods: Six sites participated in this midterm study requiring annual follow-up and echocardiographic evaluation using a standardized transthoracic echocardiography acquisition protocol., Results: There were 276 patients enrolled (age 74±8 years) and 54% were in New York Heart Association (NYHA) functional class III-IV. Follow-up from the time of valve implantation had a mean of 4.0±1.7 years with a cumulative follow-up of 1,102 patient-years. At 5 years of follow-up, 99% of patients were free of moderate or severe aortic regurgitation and 94% were in NYHA functional class I or II. Between baseline and 5 years, mean gradients increased an average of 0.4 to 4.3 mm Hg. The change in effective orifice area was appreciably small (-0.1 to -0.3 cm2) after 5 years. There were 57 deaths (4 early and 53 late) and 9 valve explants., Conclusions: The Mitroflow valve implanted in the aortic position has shown to be hemodynamically stable over a 5-year follow-up in an elderly population with a high prevalence of comorbid conditions., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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Copyright of Archivos de Cardiología de México is the property of Publicidad Permanyer SLU and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This International evidence-based nomenclature and classification consensus on the congenital bicuspid aortic valve and its aortopathy recognizes 3 types of bicuspid aortic valve: 1. Fused type, with 3 phenotypes: right-left cusp fusion, right-non cusp fusion and left-non cusp fusion; 2. 2-sinus type with 2 phenotypes: Latero-lateral and antero-posterior; and 3. Partial-fusion or forme fruste. This consensus recognizes 3 bicuspid-aortopathy types: 1. Ascending phenotype; root phenotype; and 3. extended phenotypes. [ABSTRACT FROM AUTHOR]

This International Consensus Classification and Nomenclature for the congenital bicuspid aortic valve condition recognizes 3 types of bicuspid valves: 1. The fused type (right-left cusp fusion, right-non-coronary cusp fusion and left-non-coronary cusp fusion phenotypes); 2. The 2-sinus type (latero-lateral and antero-posterior phenotypes); and 3. The partial-fusion (forme fruste) type. The presence of raphe and the symmetry of the fused type phenotypes are critical aspects to describe. The International Consensus also recognizes 3 types of bicuspid valve-associated aortopathy: 1. The ascending phenotype; 2. The root phenotype; and 3. Extended phenotypes. [ABSTRACT FROM AUTHOR]

Background: Comparative echocardiographic data on transcatheter aortic valve replacement systems from randomized trials are limited. The REPRISE III trial (Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Randomized Clinical Evaluation) is a multicenter, randomized comparison of a mechanically expanded (Lotus) versus self-expanding (CoreValve) transcatheter aortic valve replacement device. This analysis rigorously assesses Doppler-derived valve hemodynamics and the impact on outcomes at 1 year in patients with extreme/high surgical risk treated with Lotus and CoreValve from REPRISE III.Methods: REPRISE III includes patients with extreme- and high-risk aortic stenosis. Patients were enrolled at 55 centers. All transthoracic echocardiograms with Doppler were obtained following a standard protocol up to 12 months postimplant and analyzed by a core laboratory. Valve size, mean gradient, aortic valve area, and Doppler velocity index and their impact on clinical outcomes are reported. Additional parameters including paravalvular leak were evaluated using a multiparametric approach.Results: A total of 912 patients were randomly assigned (2:1 ratio; 607 Lotus:305 CoreValve). Median age was 84 years, 51% of the patients were women, and the Society of Thoracic Surgeons score was 6.8±4.1. CoreValve demonstrated lower gradients and larger aortic valve area and Doppler velocity index than Lotus at discharge; the difference decreased in subsequent follow-up up to a year (all P<0.01). Lotus had lower rates of paravalvular leak that persisted over time (P<0.05). Similar outcomes were seen when comparing each valve type by size group (small, medium, large). The hemodynamic differences between valves did not translate into worse clinical outcomes. All-cause mortality was not different between the 2 groups in any of the 3 valve sizes. When comparing patients with normal valve gradients (<20 mm Hg, n=780) with those with abnormal gradients (>20 mm Hg, n=48) in the entire patient population, all-cause mortality was not different. This was also not significant when evaluating each valve type separately. Similarly, there were no differences for aortic valve area >1.1 cm2 or <1.1 cm2 and for Doppler velocity index >0.35 or <0.35 (all P=not significant).Conclusions: Lotus had significantly greater freedom from moderate or severe paravalvular leak and smaller valve area and higher gradients than CoreValve. The hemodynamic differences were not associated with any clinical differences in the composite end point of mortality, disabling stroke, and moderate paravalvular leak or with quality of life at 1 year of follow-up.Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02202434. [ABSTRACT FROM AUTHOR]

Background: The LRT trial (Low-Risk Transcatheter Aortic Valve Replacement [TAVR]) demonstrated the safety and feasibility of TAVR in low-risk patients, with excellent 1- and 2-year outcomes. The objective of the current study is to provide the overall clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration at 4 years. Methods: The prospective, multicenter LRT trial was the first Food and Drug Administration-approved investigational device exemption study to evaluate feasibility and safety of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis. Clinical outcomes and valve hemodynamics were documented annually through 4 years. Results: A total of 200 patients were enrolled, and follow-up was available on 177 patients at 4 years. The rates of all-cause mortality and cardiovascular death were 11.9% and 3.3%, respectively. The stroke rate rose from 0.5% at 30 days to 7.5% at 4 years, and permanent pacemaker implantation rose from 6.5% at 30 days to 11.7% at 4 years. Endocarditis was detected in 2.5% of the cohort, with no new cases reported between 2 and 4 years. Transcatheter heart valve hemodynamics remained excellent post-procedure and were maintained (mean gradient 12.56±5.54 mm Hg and aortic valve area 1.69±0.52 cm2) at 4 years. At 30 days, HALT was observed in 14% of subjects who received a balloon-expandable transcatheter heart valve. There was no difference in valve hemodynamics between patients with and without HALT (mean gradient 14.94±5.01 mm Hg versus 12.3±5.57 mm Hg; P =0.23) at 4 years. The overall rate of structural valve deterioration was 5.8%, and there was no impact of HALT on valve hemodynamics, endocarditis, or stroke at 4 years. Conclusions: TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis was found to be safe and durable at 4 years. Structural valve deterioration rates were low irrespective of the type of valve, and the presence of HALT at 30 days did not affect structural valve deterioration, transcatheter valve hemodynamics, and stroke rate at 4 years. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02628899. [ABSTRACT FROM AUTHOR]

Background: The GenTAC (Genetically Triggered Thoracic Aortic Aneurysm and Cardiovascular Conditions) Registry enrolled patients with genetic aortopathies between 2007 and 2016.Objectives: The purpose of this study was to compare age distribution and probability of elective surgery for proximal aortic aneurysm, any dissection surgery, and cardiovascular mortality among aortopathy etiologies.Methods: The GenTAC study had a retrospective/prospective design. Participants with bicuspid aortic valve (BAV) with aneurysm (n = 879), Marfan syndrome (MFS) (n = 861), nonsyndromic heritable thoracic aortic disease (nsHTAD) (n = 378), Turner syndrome (TS) (n = 298), vascular Ehlers-Danlos syndrome (vEDS) (n = 149), and Loeys-Dietz syndrome (LDS) (n = 121) were analyzed.Results: The 25% probability of elective proximal aortic aneurysm surgery was 30 years for LDS (95% CI: 18-37 years), followed by MFS (34 years; 95% CI: 32-36 years), nsHTAD (52 years; 95% CI: 48-56 years), and BAV (55 years; 95% CI: 53-58 years). Any dissection surgery 25% probability was highest in LDS (38 years; 95% CI: 33-53 years) followed by MFS (51 years; 95% CI: 46-57 years) and nsHTAD (54 years; 95% CI: 51-61 years). BAV experienced the largest relative frequency of elective surgery to any dissection surgery (254/33 = 7.7), compared with MFS (273/112 = 2.4), LDS (35/16 = 2.2), or nsHTAD (82/76 = 1.1). With MFS as the reference population, risk of any dissection surgery or cardiovascular mortality was lowest in BAV patients (HR: 0.13; 95% CI: 0.08-0.18; HR: 0.13; 95%: CI: 0.06-0.27, respectively). The greatest risk of mortality was seen in patients with vEDS.Conclusions: Marfan and LDS cohorts demonstrate age and event profiles congruent with the current understanding of syndromic aortopathies. BAV events weigh toward elective replacement with relatively few dissection surgeries. Nonsyndromic HTAD patients experience near equal probability of dissection vs prophylactic surgery, possibly because of failure of early diagnosis. [ABSTRACT FROM AUTHOR]

Recent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse. The current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves. A total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (≥moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 ± 0.43 mm2 vs. 1.69 ± 0.45 mm2, p < 0.001) and lower mean gradient (8.93 ± 3.53 mmHg vs. 13.41 ± 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038). In this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated. LRT 1.0: NCT02628899 LRT 2.0: NCT03557242 • Few studies compared self-expanding vs. balloon-expandable THVs in TAVR. • These were in intermediate- and high-risk patients; data in low-risk are sparse. • We present a post hoc analysis of two trials of younger, low-risk TAVR patients. • Self-expanding THV had better hemodynamics and lower leaflet thrombosis at 30 days. • Balloon-expandable THV had lower stroke and pacemaker implantation at 30 days. [ABSTRACT FROM AUTHOR]

Background: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.Objectives: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.Methods: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.Results: A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year.Conclusions: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788). [ABSTRACT FROM AUTHOR]