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Background: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR)., Methods: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm 2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority)., Results: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm 2 and 1.50 cm 2 ; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups., Conclusions: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction., Objectives: This study aimed to determine whether device position and asymmetry are associated with these outcomes., Methods: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated., Results: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027)., Conclusions: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered., Competing Interests: Funding Support and Author Disclosures Dr Whisenant is a consultant for Edwards Lifesciences. Dr Unbehaun is a proctor for Edwards Lifesciences. Dr Erlebach has received speaker honoraria from Medtronic and Abbott; and is a proctor for Abbott. Dr Guerrero has received institutional research grant support from Edwards Lifesciences. Dr Bruschi is a consultant for Abbott. Dr Rudolph has received speaker honoraria from Edwards Lifesciences; and is a proctor for Edwards Lifesciences. Dr Andreas is a consultant for Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, Zoll, and AbbVie; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Dvir is a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.)

Objectives: The aim of this study was to analyse the outcome of patients between 50 and 69 years of age undergoing biological or mechanical aortic valve replacement., Methods: Data were collected from the German Aortic Valve Registry. Data were analysed regarding baseline characteristics and outcome parameters such as 5-year survival, stroke and reintervention., Results: In total., 3046 patients undergoing isolated surgical aortic valve replacement between 2011 and 2012 were investigated and a propensity score matching was performed. Within this period, 2239 patients received a biological prostheses, while 807 patients received a mechanical prosthesis. Mean age in the biological group was 63.07 (±5.11) and 57.34 (±4.67) in the mechanical group (standardized mean difference 1.172). In the overall cohort, there were more female patients in the biological group (32.7% vs 28.4%) and log EuroSCORE I was higher (5.41% vs 4.26%). After propensity matching (610 pairs), there was no difference in the mortality at 5-year follow-up (12.1% biological vs 9.2% mechanical P = 0.05) nor for reoperation/reintervention (2.5% biological vs 2.0% mechanical, P = 0.546). Patients undergoing mechanical aortic valve replacement suffered from a higher stroke rate 3.3% vs 1.5% (P = 0.04) at 5-year follow-up., Conclusions: Aortic valve replacement with biological or mechanical prostheses showed similar 5-year outcomes for survival and reoperation in a propensity-matched cohort, but significantly increased stroke rate after mechanical aortic valve replacement. This could influence the choice of a mechanical valve in younger patients., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Bioprosthetic valve thrombosis may have implications for valve function and durability., Objectives: Using a novel glycoprotein IIb/IIIa receptor radiotracer 18F-GP1, we investigated whether positron emission tomography (PET)-computed tomography (CT) could detect thrombus formation on bioprosthetic aortic valves., Methods: Ex vivo experiments were performed on human platelets and explanted bioprosthetic aortic valves. In a prospective cross-sectional study, patients with either bioprosthetic or normal native aortic valves underwent echocardiography, CT angiography, and 18F-GP1 PET-CT., Results: Flow cytometric analysis, histology, immunohistochemistry, and autoradiography demonstrated selective binding of 18F-GP1 to activated platelet glycoprotein IIb/IIIa receptors and thrombus adherent to prosthetic valves. In total, 75 participants were recruited: 53 with bioprosthetic valves (median time from implantation 37 months [IQR: 12-80 months]) and 22 with normal native aortic valves. Three participants had obstructive valve thrombosis, and a further 3 participants had asymptomatic hypoattenuated leaflet thickening on CT angiography. All bioprosthetic valves, but none of the native aortic valves, demonstrated focal 18F-GP1 uptake on the valve leaflets: median maximum target-to-background ratio 2.81 (IQR: 2.29-3.48) vs 1.43 (IQR: 1.28-1.53) (P < 0.001). Higher 18F-GP1 uptake was independently associated with duration of valve implantation and hypoattenuated leaflet thickening. All 3 participants with obstructive valve thrombosis were anticoagulated for 3 months, leading to resolution of their symptoms, improvement in mean valve gradients, and a reduction in 18F-GP1 uptake., Conclusions: Adherence of activated platelets is a common and sustained finding on bioprosthetic aortic valves. 18F-GP1 uptake is higher in the presence of thrombus, regresses with anticoagulation, and has potential use as an adjunctive clinical tool. (18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis; NCT04073875)., Competing Interests: Funding Support and Author Disclosures This work was funded by the British Heart Foundation, London, United Kingdom (RG/16/10/32375 and PG/19/40/34422). The Edinburgh Clinical Research Facilities and Edinburgh Imaging facility is supported by the National Health Service Research Scotland (NRS) through National Health Service Lothian Health Board. This work and Drs Bing, Tzolos, Williams, Dweck, and Newby are supported by the British Heart Foundation (PG/19/40/34422, FS/ICRF/20/26002, FS/CRTF/20/24086, FS/14/78/31020, CH/09/002, RG/16/10/32375, RE/18/5/34216, FS/SCRF/21/32010). Dr van Beek is supported by the Scottish Imaging Network. Dr Sellers is supported by fellowships from the Michael Smith Foundation for Health Research and the Canadian Institutes of Health Research. Drs Koglin and Stephens are employees of Life Molecular Imaging GmbH, who provided reagents for radiotracer production. Dr Leipsic is supported by a Canadian Research Chair in Advanced CardioPulmonary Imaging and the Jon DeHaan Award for Innovation in Cardiology; is a consultant for Edward Lifesciences; and provides computed tomography core laboratory services to Edwards Lifesciences, Medtronic, Neovasc, Aegis, and Tendyne, for which no direct compensation is received. Dr Williams is supported by The Chief Scientist Office of the Scottish Government Health and Social Care Directorates (PCL/17/04). Dr Newby is the recipient of a Wellcome Trust Senior Investigator Award (WT103782AIA). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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

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.)

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

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]., Methods and Results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]., Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

Objectives: The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus., Background: TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice., Methods: The RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data., Results: One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients)., Conclusions: One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302)., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

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

Background: Surgical aortic valve replacement using conventional biological valves (CBVs) is the standard of care for treatment of old patients with aortic valve disease. Recently, rapid deployment valves (RDVs) have been introduced., Objectives: The purpose of this study was to report the nationwide German experience concerning RDVs for treatment of aortic valve stenosis and provide a head-to-head comparison with CBVs., Methods: A total of 22,062 patients who underwent isolated surgical aortic valve replacement using CBV or RDV between 2011 and 2015 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for CBVs and RDVs using 1:1 propensity score matching. Furthermore, 3 RDVs were compared with each other., Results: A total of 20,937 patients received a CBV, whereas 1,125 patients were treated with an RDV. Patients treated with an RDV presented with significantly reduced procedure (160 min [25th to 75th percentile: 135 to 195 min] vs. 150 min [25th to 75th percentile: 127 to 179 min]; p < 0.001), cardiopulmonary bypass (83 min [25th to 75th percentile: 68 to 104 min] vs. 70 min [25th to 75th percentile: 56 to 87 min]; p < 0.001), and aortic cross clamp times (60 min [25th to 75th percentile: 48 to 75 min] vs. 44 min [25th to 75th percentile: 35 to 57 min]; p < 0.001), but showed significantly elevated rates of pacemaker implantation (3.7% vs. 8.8%; p < 0.001) and disabling stroke (0.9% vs. 2.2%; p < 0.001), whereas in-hospital mortality was similar (1.7% vs. 2.2%; p = 0.22). These findings persisted after 1:1 propensity score matching. Comparison of the 3 RDVs revealed statistically nonsignificant different pacemaker rates and significantly different post-operative transvalvular gradients., Conclusions: In this large, all-comers database, the incidence of pacemaker implantation and disabling stroke was higher with RDVs, whereas no beneficial effect on in-hospital mortality was seen. The 3 RDVs presented different complication profiles with regard to pacemaker implantation and transvalvular gradients. (German Aortic Valve Registry [GARY]; NCT01165827)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement., Methods and Results: Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The study was 100% monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium (VARC-1) criteria. There were 1015 patients enrolled with 996 attempted TAVI procedures. Mean age was 81 years, and mean logistic EuroSCORE was 19.3 ± 12.3%. Five-year follow-up was available on 465 (46.7%) patients. At 5 years, the rate of all-cause mortality was 50.7% (95% confidence interval: 46.7%, 54.5%), and the rate of major stroke was 5.4%. Haemodynamic measures remained consistent for paired patients with a mean aortic valve gradient of 8.8 ± 4.4 mmHg (n = 198) and an effective orifice area of 1.7 ± 0.4 cm2 (n = 123). Aortic regurgitation (AR) decreased over time and among paired patients dropped from 12.8% to 8.0% moderate AR at 5 years (n = 125). Of the 860 patients with echocardiographic data or a reintervention after 30 days, there were 22 (2.6%) patients meeting the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients with a reintervention >30 days., Conclusion: Five-year results in real-world, elderly, high-risk patients undergoing TAVI with a self-expanding bioprosthesis provided evidence for continued valve durability with low rates of reinterventions and haemodynamic valve dysfunction., Trial Registration: ClinicalTrials.gov, NCT01074658., (© The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair., Objectives: This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR])., Methods: From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria., Results: A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005)., Conclusions: The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR)., Background: Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR., Methods: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria., Results: A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m 2 , STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively., Conclusions: TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background  Since biological valve recipients are likely to need a redo procedure in the future for valve deterioration, we hypothesized patients might be more fearful about the progression of their disease than patients after aortic valve replacement (AVR) with a mechanical valve. The aim of this study is to compare the quality of life (QOL) and anxiety in patients who have undergone biological versus mechanical AVR. Method  A total of 56 patients after mechanical AVR (mean age: 64.4 ± 8.17 years) and 66 patients after biological AVR (mean age: 64.8 ± 11.05 years) received three questionnaires 5.66 (± 2.68) years after surgery, including: The short form-36 (SF-36) to assess QOL, the fear of progression questionnaire (FOP), and the cardiac anxiety questionnaire (CAQ) to assess general anxiety, anxiety related to cardiac symptoms, and anxiety about progression of heart disease and valve and anticoagulation-specific questions. Results  No significant differences were found for all categories of the SF-36. The FOP showed significantly favorable values for the biological AVR group. The CAQ showed a tendency in the subscale "avoidance" (i.e., avoidance of pulse increase) and "attention" towards more favorable values for the biological AVR group. Conclusions  In contrast to our hypothesis, patients after mechanical AVR show significantly higher anxiety values for the FOP, and a tendency toward higher values for "avoidance" (i.e., avoidance of pulse increase). Partnership concerns, especially in terms of sexuality can be explained by factors that are recognizable for the partner, such as valve sound. These data provide evidence that factors that are continuously present after mechanical AVR, such as valve sound or anticoagulation might affect wellbeing stronger than the certainty of reoperation in the future after biological AVR. We conclude that implantation of a biological prosthesis can be justified in younger patients with regards to QOL., (Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: The St Jude Medical (SJM) Trifecta bioprosthesis is a recently introduced stented trileaflet pericardial valve designed for supra-annular replacement of the aortic valve (AVR). We sought to evaluate the short-term clinical outcome and haemodynamic performance of the Trifecta valve after AVR., Methods: A total of 837 patients with severe symptomatic aortic valve stenosis or regurgitation underwent AVR with the SJM Trifecta aortic valve prosthesis between January 2009 and March 2013. All intra- and postoperative data were collected prospectively. At discharge, transthoracic echocardiography was performed. A complete set of echocardiographic data was available in 723 patients., Results: Adjusted mean systolic pressure gradients (MPGs) for valve sizes 19 (n = 37/4.4%), 21 (n = 192/22.9%), 23 (n = 263/31.4%), 25 (n = 202/24.1%), 27 (n = 100/11.9%) and 29 mm (n = 42/5.0%) were 8.6 ± 1.1, 8.7 ± 0.4, 7.2 ± 0.3, 6.2 ± 0.3, 5.6 ± 0.3 and 3.9 ± 0.4 mmHg, respectively. Mean effective orifice area (EOA) for valve sizes 19, 21, 23, 25, 27 and 29 mm were 1.5 ± 0.09, 1.6 ± 0.04, 1.9 ± 0.03, 2.0 ± 0.03, 2.2 ± 0.05 and 2.7 ± 0.01 cm(2), respectively. No patient-prosthesis mismatch (PPM) was seen in 71.3% of patients (EOAI >0.85 cm(2)/m(2)). Moderate mismatch (EOAI 0.65-0.85 cm(2)/m(2)) was observed in 23.9% of patients, whereas severe PPM (EOAI <0.65 cm(2)/m(2)) occurred in 4.4% of patients. No malfunction of the prosthesis, endocarditis, valve thrombosis or relevant aortic regurgitation necessitating surgical revision was observed until discharge., Conclusions: The SJM Trifecta valve reveals an excellent early haemodynamic performance with low residual MPGs and a low incidence of PPM. Studies with longitudinal clinical and echocardiographic assessments with longer term follow-up evaluation including a comparison with other contemporary bioprostheses are needed., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets for implantation that would improve hemodynamics after ViV., Methods and Results: Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated postprocedural gradients (mean ≥20 mm Hg). Optimal implantation depths were defined by receiver operating characteristic curve. A total of 292 consecutive patients (age, 78.9±8.7 years; 60.3% male; 157 CoreValve Evolut and 135 Sapien XT) were evaluated. High implantation was associated with significantly lower rates of elevated gradients in comparison with low implantation (CoreValve Evolut, 15% versus 34.2%; P=0.03 and Sapien XT, 18.5% versus 43.5%; P=0.03, respectively). Optimal implantation depths were defined: CoreValve Evolut, 0 to 5 mm; Sapien XT, 0 to 2 mm (0-10% frame height); sensitivities, 91.3% and 88.5%, respectively. The strongest independent correlate for elevated gradients after ViV was device position (high: odds ratio, 0.22; confidence interval, 0.1-0.52; P=0.001), in addition to type of device used (CoreValve Evolut: odds ratio, 0.5; confidence interval, 0.28-0.88; P=0.02) and surgical valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51-6.45; P=0.002)., Conclusions: High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self- and balloon-expandable transcatheter valves. These clinical evaluations support specific implantation targets to optimize hemodynamics after ViV., (© 2016 American Heart Association, Inc.)

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

Importance: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed., Objective: To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves., Design, Setting, and Participants: Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves., Main Outcomes and Measures: Survival, stroke, and New York Heart Association functional class., Results: Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008)., Conclusions and Relevance: In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.

Background and Aim of the Study: The study aim was to examine the hemodynamic performance of the BioValsalva porcine aortic valve conduit in the aortic root position., Methods: Between February 2007 and April 2012, a total of 223 patients underwent aortic root replacement at the authors' institution. The BioValsalva valved conduit was implanted in 131 patients, and 86 of these patients (mean age 64.7 +/- 9.7 years) consented to participate in the present study. The parameters assessed to evaluate prosthetic valve function included mean pressure gradient (MPG) as measured by transthoracic Doppler echocardiography, and the effective orifice area (EOA) by means of the continuity equation. Hemodynamic data were obtained from all 86 patients within 10 days and six months postoperatively., Results: The mean aortic cross-clamp time was 103 +/- 30 min. Concomitant procedures were performed in 50 patients (56.5%). Four patients developed valve dysfunction due to endocarditis, and underwent a reoperation without the need to perform a redo Bentall. The early MPG across the implanted valve was 12 +/- 4.6 mmHg (range: 4-24.8 mmHg), and the early mean EOA was 1.81 +/- 0.6 cm2 (range: 0.9-3.2 cm2). After six months the MPG was 11.6 +/- 4.6 mmHg (range: 2.2-25.5 mmHg) and the EOA was 1.69 +/- 0.43 cm2 (range: 0.8-2.6 cm2)., Conclusion: Based on its special design with a stentless valve, which is not incorporated into the proximal suture line, the BioValsalva conduit has an advantage over intraoperatively prepared conduits in cases of reoperation. Besides simplified intraoperative handling, the BioValsalva conduit exhibits good systolic hemodynamic performance with large EOAs.

The Medtronic Engager aortic valve system is a second-generation transcatheter aortic valve implantation bioprosthesis combined with a delivery system designed for over-the-wire transapical implantation of the valve. The self-expandable stent has control arms to be placed into the native aortic sinuses to achieve correct positioning of the bioprosthesis in a predefined height. The purpose of the lower skirt is to reduce paravalvular leakage. A three-leaflet, bovine pericardium valve is mounted on the stent. The implantation is facilitated by the control arms and rotational positioning of the commissural posts. A multicentre feasibility study showed promising results. The results from the following European pivotal trial led to CE mark approval in 2013. Here, we describe technical details of the device and its implantation technique and highlight special steps of the procedure.

Background: Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry., Methods and Results: The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients., Conclusions: The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

Objectives: This study sought to review the acute procedural outcomes of patients who underwent transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation at the German Heart Center, Munich, and to summarize the existing literature on TAV-in-SAV implantation (n = 47)., Background: There are several case reports and small case series describing transcatheter aortic valve implantation for a failing surgical aortic valve bioprosthesis (TAV-in-SAV implantation)., Methods: From January 2007 to March 2011, 20 out of 556 patients underwent a TAV-in-SAV implantation at the German Heart Center Munich. Baseline characteristics and clinical outcome data were prospectively entered into a dedicated database., Results: The mean patient age was 75 ± 13 years, and the mean logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons' Risk Model scores were 27 ± 13% and 7 ± 4%, respectively. Of the 20 patients, 14 had stented and 6 had stentless surgical bioprostheses. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, California). Successful implantation of a TAV in a SAV with the patient leaving the catheterization laboratory alive was achieved in 18 of 20 patients. The mean transaortic valve gradient was 20.0 ± 7.5 mm Hg. None-to-trivial, mild, and mild-to-moderate paravalvular aortic regurgitation was observed in 10, 6, and 2 patients, respectively. We experienced 1 intraprocedural death following pre-implant balloon aortic valvuloplasty ("stone heart") and 2 further in-hospital deaths due to myocardial infarction., Conclusions: TAV-in-SAV implantation is a safe and feasible treatment for high-risk patients with failing aortic bioprosthetic valves and should be considered as part of the armamentarium in the treatment of aortic bioprosthetic valve failure., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

With an aging population, improvement in life expectancy, and significant increase in the use of bioprosthetic valves, structural valve deterioration will become more and more prevalent. The operative mortality for an elective redo aortic valve surgery is reported to range from 2% to 7%, but this percentage can increase to more than 30% in high-risk and nonelective patients. Because transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation represents a minimally invasive alternative to conventional redo surgery, it may prove to be safer and just as effective as redo surgery. Of course, prospective comparisons with a large number of patients and long-term follow-up are required to confirm these potential advantages. It is axiomatic that knowledge of the basic construction and dimensions, radiographic identification, and potential failure modes of SAV bioprostheses is fundamental in understanding key principles involved in TAV-in-SAV implantation. The goals of this paper are: 1) to review the classification, physical characteristics, and potential failure modes of surgical bioprosthetic aortic valves; and 2) to discuss patient selection and procedural techniques relevant to TAV-in-SAV implantation., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background and Aim of the Study: The study aim was to assess long-term morbidity and mortality with special regard to prosthesis durability after aortic root replacement with the Hancock bioprosthetic porcine conduit., Methods: Between 1975 and 2004, a total of 81 patients (55 males, 26 females; mean age 58 +/- 18 years) underwent aortic root replacement with the Hancock conduit for aortic dissection (n = 22; 27%), ascending aortic aneurysm (n = 57; 70%), or porcelain aorta (n = 2; 3%). Twenty-five patients (31%) underwent an emergency operation, 12 (15%) presented with Marfan syndrome, and eight (10%) had undergone previous cardiac surgery. Concomitant procedures were performed in 26 cases (32%). The follow up was 98% complete; the mean follow up was 4.8 +/- 4.0 years (range: 1 day to 16.7 years), and the cumulative follow up was 403 patient-years. Actuarial event-free rates were calculated, and valve-related complications classified according to guidelines for reporting morbidity and mortality after cardiac valvular operations., Results: There were seven (9%) operative deaths and four (5%) in-hospital deaths. Actuarial survival rates at five and 10 years (excluding operative deaths) were 77.0 +/- 5.3% and 54.0 +/- 7.5%, respectively. Actuarial freedom from aortic valve reoperation at five and 10 years was 98 +/- 1.6% and 64 +/- 10.2%, from structural valve deterioration 88.1 +/- 4.7% and 49.9 +/- 9.6%, from thromboembolic events 87.4 +/- 4.6% and 75.1 +/- 9.5%, and from major bleeding events 90.2 +/- 3.9% and 75.4 +/- 8.1%, respectively. Among redo procedures, the stentless Hancock valve could be excised without separating the synthetic graft from the left ventricular outflow tract, and a stented valve prosthesis thus implanted. Hence, it was possible to avoid a second Bentall operation., Conclusion: The long-term survival rates after aortic root replacement with the bioprosthetic Hancock conduit were reasonable for this demanding patient cohort. However, the durability of the prosthesis was inferior to that reported for the stented Hancock valve substitute. The key benefit of this bioprosthetic valved conduit was the simplified redo procedure.

Background: Complete supraannular placement of an aortic bioprosthesis is one approach to optimize the hemodynamic result of an aortic valve replacement. It is achieved with the combination of a special valve design and the supraannular sewing technique with noneverted mattress sutures. We evaluated 5 bioprostheses designed for complete supraannular placement to assess potential hemodynamic differences caused by factors (eg, valve material) other than implantation position., Methods and Results: In 336 patients (mean age, 72.0+/-7.1 years; 143 women), hemodynamics including mean pressure gradients, effective orifice areas, and indices and incidence of patient-prosthesis mismatch were evaluated 6 months after surgery. Annulus diameter was measured during surgery. Patients received the Carpentier Edwards Perimount Magna (Magna, n=169), the Medtronic Mosaic (Mosaic, n=46), the Mosaic Ultra (Ultra, n=17), the SJM Epic Supra (Epic, n=46), and the Sorin Soprano (Soprano, n=58). For small annulus sizes (<23 mm), the mean pressure gradients of the Magna (11.82+/-4.8 mm Hg) were significantly lower than the Mosaic (16.04+/-6.1 mm Hg) and the Ultra (22.0+/-4.1 mm Hg), and the Soprano (13.3+/-5.2 mm Hg) was hemodynamically superior to the Ultra. For medium (23 to 24 mm) and large (>24 mm) annulus sizes, the mean pressure gradients of the Magna were lower than the Epic (10.0+/-3.5 mm Hg versus 14.9+/-6.4 mm Hg; 9.9+/-4.0 mm Hg versus 18.6+/-12.7 mm Hg). Furthermore, in patients with large annulus size, the mean pressure gradients of the Soprano (11.4+/-3.8 mm Hg) were lower compared with the Epic (18.5+/-12.7 mm Hg). Severe patient-prosthesis mismatch was observed more frequently in patients with the Mosaic (12/46; 26.1%) and the Ultra (3/17; 17.6%) prostheses., Conclusions: Complete supraannular placement cannot prevent high pressure gradients or patient-prosthesis mismatch thoroughly, but the choice of a bovine prosthesis can optimize hemodynamic performance.

Background and Aim of the Study: Although the long-term clinical outcome after aortic valve replacement (AVR) with the Sorin Mitroflow pericardial bioprosthesis has been well described, few data are available with regards to hemodynamic performance. On the basis of its specialized design, with the pericardium mounted on the outside of the stent, the Mitroflow valve is considered to provide optimal opening and orifice areas., Methods: Between February 2006 and April 2007, a total of 127 patients (66 females, 61 males; mean age 77.6 +/- 5.2 years) underwent AVR with the Mitroflow valve at the authors' institution. Echocardiography was performed at discharge in 91 patients, while a six-month follow up examination was conducted in 78 (including ergometer hemodynamics in 25 cases)., Results: The mean systolic pressure gradient (MPG) ranged from 19.7 +/- 3.3 mmHg (size 19 valve) to 12.4 +/- 2.4 mmHg (size 27 valve), and the mean effective orifice area (EOA) from 0.96 +/- 0.0 cm2 (size 19 valve) to 2.36 +/- 0.4 cm2 (size 27 valve). The incidence of mild-to-moderate and severe prosthesis-patient mismatch (PPM) was 33% and 10% at the six-month follow up. During exercise (25 W-100 W), the MPG increased from 17.1 +/- 3.6 mmHg to 23.6 mmHg in valve sizes 19 to 21, and from 12.2 +/- 3.6 mmHg to 15.9 +/- 2.5 mmHg in valve sizes 23 to 27. The effective orifice fraction (EOF = EOA/annulus area) was 38 +/- 7%., Conclusion: The Mitroflow valve exhibits an adequate MPG and EOA, as might be expected for a pericardial bioprosthesis. Of note, the gradient increase during exercise was low, especially for the larger valve sizes. Due to its special design, the Mitroflow prosthesis shows a large opening, as demonstrated by the high EOF. These data relating to the EOA of all prosthesis sizes may help surgeons to select the minimum prosthesis size in order to prevent PPM.

Background: The purpose of this study was to evaluate the long-term performance of the St. Jude Medical Biocor stented porcine prosthesis in the aortic position., Methods: From January 1985 to December 1996, 455 patients admitted for aortic valve replacement were consecutively enrolled in this study. The mean age was 72.5 +/- 9 years, 18 patients (3.5%) had had previous cardiac surgery, and coronary artery bypass grafting was performed in 171 patients (37.6%). Follow-up was complete in 99.6%; up to 21 years were covered. Actuarial event-free rates are given as mean +/- standard error and adverse events were classified according to the guidelines for reporting morbidity and mortality after cardiac valvular operations., Results: Cumulative follow-up time was 3,321 patient-years with a mean follow-up of 8.2 years. The actuarial survival rate after 20 years was 9.4% +/- 2.8%. The actuarial rates for freedom from structural valve deterioration were 93.1% +/- 1.7% at 10 years, 88.4% +/- 3.5% at 15 years, and 70.3% +/- 10.9% at 20 years. The actuarial rates for freedom from reoperation due to structural valve deterioration were 91.9% +/- 1.6% at 10 years, 90.6% +/- 2.1% at 15 years, and 86.5% +/- 4.5% at 20 years., Conclusions: This study presents one of the largest series of St. Jude Medical Biocor aortic valves in the world. Results indicate an age-dependent risk of structural valve degeneration beginning as soon as 7 years postoperatively for patients below the age of 65 years, but show a low overall incidence of valve-related complications and excellent durability.

Background and Aim of the Study: The St. Jude Medical Epic Supra (ES) valve is a new porcine bioprosthesis designed for complete supra-annular implantation. To date, no in-vivo data regarding the hemodynamic and clinical performance of this valve are available. The study aim was to compare the hemodynamic performance of the ES valve with the completely supra-annular Medtronic Mosaic (MM) porcine valve., Methods: Between July 2000 and April 2006, 83 patients (39 males, 44 females) underwent aortic valve replacement with either the ES (n = 44) or MM (n = 39) bioprosthesis. Hemodynamic performance was evaluated echocardiographically at six months postoperatively. Comparison between the valves was performed by dividing the patient groups according to their intraoperatively measured tissue annulus diameter rather than the labeled valve size., Results: The internal diameter and sewing ring diameter differed in ES and MM valves with the same labeled size. For example, in valves labeled '23' the internal diameter/sewing ring diameters were 21.5 and 29.3 mm in the ES valve versus 20.5 and 30 mm in the MM. The mean pressure gradients (MPG) for patients with ES or MM valves were 15.5 +/- 4.5 or 14.8 +/- 5.1 mmHg for annulus diameter < or =22 mm, 14.6 +/- 6.4 or 13.9 +/- 3.6 for annulus diameter 23-24 mm, and 15.3 +/- 3.8 or 13.4 +/- 4.2 mmHg for annulus diameter > or =25 mm. No significant differences were identified in the hemodynamic data, including MPG, effective orifice area (EOA) and effective orifice area index (EOAI). The incidence of moderate or severe patient-prosthesis mismatch (PPM) was 40% (n = 18) and 5% (n = 1) in patients with ES valves, and 26% (n = 10) or 23% (n = 9) in patients with MM valves (p = 0.01). In patients with an annulus size < or =22 mm, severe PPM occurred in 29% (n =5) of patients with MM valves but in none of those with ES valves., Conclusion: The hemodynamic performance of the ES valve was comparable to that of the well-established MM valve. The incidence of severe PPM was lower in patients with ES valves than MM valves, presumably due to the somewhat larger EOA values in patients with a small aortic annulus (<25 mm).

We successfully implanted a bioprosthetic aortic valve via the right subclavian artery within the framework of the CoreValve transapical aortic valve replacement (TAVR) ReValving (CoreValve, Irvine, CA, USA) clinical trial on November 20, 2007, at the Clinic for Cardiovascular Surgery at the German Heart Center Munich, Technical University Munich. The self-expanding aortic valve prosthesis is primarily designed for retrograde delivery across the aortic valve. The described approach via the right subclavian artery was performed because of severe peripheral vascular disease of the femoral and iliac arteries, as well as the left subclavian artery, and because a transapical delivery system was not available at the time of surgery.

Objective: Aortic valve replacement in patients with a small aortic annulus is often associated with increased pressure gradients. For this reason, prostheses for completely supra-annular placement have been developed. To evaluate the potential benefit of this design, the present study compared the effectiveness of 1 intra-supra-annular bioprosthesis and 3 completely supra-annular bioprostheses in patients with an aortic annulus diameter of 23 mm or less., Methods: Between August 2000 and December 2004, each of 192 patients requiring aortic valve replacement with an intraoperatively measured aortic annulus diameter of 23 mm or less received one of the following bioprostheses: the stented bovine Sorin Soprano bioprosthesis (n = 28) (Sorin Group, Saluggia, Italy), the Carpentier-Edwards Perimount bioprosthesis (n = 50) (Edwards Lifesciences, Irvine, Calif), the Carpentier-Edwards Perimount Magna bioprosthesis (n = 70) (Edwards Lifesciences), or the stented porcine Medtronic Mosaic (n = 44) (Medtronic Inc, Minneapolis, Minn) bioprosthesis. After 6 months, hemodynamic data at rest and during exercise were obtained by echocardiography in 142 patients., Results: The pericardial valves showed lower mean systolic pressure gradients, larger effective orifice areas and indices, and superior effective orifice fractions than did the porcine valve (P < .05) (Carpentier-Edwards Perimount: 10.9 +/- 3.6 mm Hg, 1.59 +/- 0.41 cm2, 0.9 +/- 0.25 cm2/m2, 41.9% +/- 9.6%; Carpentier-Edwards Perimount Magna 10.1 +/- 3.8 mm Hg, 1.64 +/- 0.38 cm2, 0.93 +/- 0.22 cm2/m2, 45.1% +/- 10.2%; Sorin Soprano 13.5 +/- 5.0 mm Hg, 1.64 +/- 0.32 cm2, 0.92 +/- 0.15 cm2/m2, 45.8% +/- 9.0%; vs Medtronic Mosaic 15.5 +/- 5.2 mm Hg, 1.31 +/- 0.42 cm2, 0.75 +/- 0.24 cm2/m2, 35.2% +/- 10.0%, respectively). The lowest mean systolic pressure gradients were found after the implantation of the Carpentier-Edwards Perimount Magna. Effective orifice areas, indices, and fractions of the pericardial valves did not show significant differences., Conclusions: In patients with small aortic roots, transvalvular gradients and effective orifice area showed a tendency to superior results in pericardial valves compared with the porcine bioprosthesis. However, the completely supra-annular design does not necessarily lead to superior hemodynamic results compared with the intra-supra-annular position.

Background and Aim of the Study: Stentless valves are considered to exhibit better hemodynamics after aortic valve replacement (AVR) compared to stented valves. However, a new generation of stented bioprostheses for completely supra-annular implantation has been designed to optimize the ratio of the effective orifice area (EOA) of the prosthesis and aortic annulus area. The study aim was to determine whether a stentless valve implanted in the subcoronary technique renders larger orifice areas and lower transvalvular pressure gradients at rest and exercise compared to a completely supra-annular stented device., Methods: Twenty patients underwent AVR for aortic stenosis with the St. Jude Medical (SJM) Toronto Root stentless porcine bioprosthesis, using a subcoronary implantation technique. Through the authors' institutional database, 20 additional patients were identified who had undergone AVR with the Medtronic Mosaic stented completely supra-annular porcine bioprosthesis. The patient groups were not matched for labeled valve size, but for annulus diameter measured intraoperatively using Hegar's dilators. Hemodynamic performance was assessed by transthoracic echocardiography at discharge (early) and by rest and stress echocardiography at six months postoperatively (mid-term)., Results: Transvalvular mean pressure gradients (MPG) at rest were significantly lower in the stentless group, but cardiac output was similar in both groups. Stress echocardiography also revealed significantly lower gradients at 25 W and 50 W exercise in the stentless group. The EOA index (EOAI), grouped by annulus diameter, tended to be larger in the stentless group and showed no severe patient-prosthesis mismatch (PPM; EOAI <0.65 cm2/m2) which, in contrast, occurred in three patients (15%) in the stented group (p = 0.072)., Conclusion: In summary, the SJM Toronto Root porcine stentless bioprosthesis in the subcoronary position showed lower MPGs and larger EOAs at rest and during exercise compared to the Medtronic Mosaic porcine stented bioprosthesis. Therefore, physically active patients in particular may benefit from use of the stentless valve. Because of its larger EOA, a stentless valve should be implanted if severe PPM is expected.

Background and Aim of the Study: The study aim was to evaluate the clinical and hemodynamic performance of the Sorin Soprano bioprosthesis in the aortic position., Methods: Rest and stress echocardiography were performed at six months after surgery in 57 patients who underwent aortic valve replacement with the stented Soprano bioprosthesis. The exercise protocol included workloads of 25, 50, 75 and 100 W, each of 2 min duration., Results: Thirty-day mortality was 1.8% (n = 1). Due to malperfusion of the coronary arteries, two Soprano prostheses had to be replaced by a different prosthesis, and one patient received coronary artery bypass grafts. One patient developed bacterial endocarditis of his prosthesis at seven months postoperatively and died as a result of a fulminant sepsis. There were no other prosthesis-related adverse events. Mean pressure gradients (MPG) ranged from 7.8 to 15.9 mmHg, effective orifice areas (EOA) from 1.25 to 2.98 cm2, EOA index (EOAI) from 0.79 to 1.43 cm2/m2, and EOA fraction from 34 to 45%. Stress echocardiography showed no significant increase in MPG up to 50 W, and MPGs did not exceed 35 mmHg at 75 and 100 W., Conclusion: Initial hemodynamic results showed low MPGs during rest and exercise. The EOAI was large due to completely supra-annular placement of the Soprano valve. The difficulty of complete supraannular placement is that the prosthesis is positioned relatively high, especially in narrow aortic roots, and this may handicap coronary artery perfusion. Patient selection with suitable aortic root anatomy is crucial to achieve the benefit of completely supra-annular implantation without coronary ostium deterioration.

Background: Complete supraannular placement and smaller stent design allow the implantation of a Perimount Magna bioprosthesis with a larger inner diameter than that of a standard Perimount. This study compares the hemodynamic performance and the incidence of patient-prosthesis mismatch (PPM) of both prostheses., Methods: 128 patients underwent aortic valve replacement, receiving either a Magna (n = 57) or a standard (n = 71) prosthesis. Inner aortic annulus diameter was measured intraoperatively by a hegar dilator to match echocardiographically obtained results to the annulus diameter instead of matching them to labelled valve size., Results: The Magna was significantly superior with respect to mean pressure gradient and effective orifice area in patients with an annulus diameter of 22-23 mm. In patients with an annulus diameter < 22 mm or > 23 mm, there was a non-significant trend towards superior hemodynamics in the Magna group. Severe PPM (effective orifice area index < or = 0.65 cm (2)/m (2)) was present in 11.1% (Magna) vs. 42.1% (Standard) of patients with an annulus diameter < 22 mm; in 0% (Magna) vs. 13.8% (Standard) with an annulus diameter of 22-23 mm; no PPM was seen in patients with annulus diameter > 23 mm in both groups., Conclusions: The Perimount Magna had a significantly reduced incidence of patient-prosthesis mismatch and superior hemodynamics compared to the standard Perimount.

Objectives: The present study evaluates complete supra-annular bioprostheses in patients with an aortic annulus of 18 to 23 mm in diameter., Background: Aortic valve replacement in patients with small aortic annulus using stented bioprostheses is often associated with unsatisfactory hemodynamic results and high incidence of patient-prosthesis mismatch., Methods: Between February 2000 and January 2004, 156 patients with aortic valve disease and an aortic annulus of 18 to 23 mm in diameter received the stented bovine Soprano (Sorin Biomedica Cardio, Saluggia, Italy) (n = 18), Perimount (Edwards Lifesciences, Irvine, California) (n = 52), Perimount Magna (Edwards Lifesciences) (n = 42), or the stented porcine Mosaic (Medtronic Inc., Minneapolis, Minnesota) (n = 44) bioprostheses. Intraoperatively, the surgeon measured the aortic annulus diameter by inserting a hegar dilator. Thus, postoperative hemodynamic results could be referred to the patient's aortic annulus diameter instead of referring the results to the labeled valve size. This allows for objective comparisons between different valve types., Results: There was no significant difference in hemodynamic results between the different valve types in patients with an aortic annulus 18 to 20 mm. In patients with an annulus 21 to 23 mm, the Magna was significantly superior to the other investigated devices in mean pressure gradient, effective orifice area, and incidence of patient-prosthesis mismatch. There was no significant difference between the complete supra-annular bioprostheses Mosaic and Soprano and the intra-supra-annular Perimount valve., Conclusions: In patients with an aortic annulus of 18 to 20 mm in diameter, hemodynamic performance is independent of the implanted stented valve type and the annular position. Root enlargement or stentless valves may be beneficial alternatives. Patients with annulus diameter 21 to 23 mm benefit from the Magna in complete supra-annular position leading to superior hemodynamic results.

Objective: This prospective randomized study compares a porcine with a bovine bioprosthesis in the aortic position with regard to hemodynamic performance during exercise., Methods: Between August of 2000 and December of 2002, 136 patients underwent aortic valve replacement with the porcine Medtronic Mosaic (n = 66) or the bovine Carpentier-Edwards Perimount (n = 70) bioprosthesis. Transthoracic echocardiography was performed to assess hemodynamic and dimensional data preoperatively and 10 months postoperatively; the latter follow-up included stress echocardiography with treadmill exercise., Results: At rest and during exercise (25 and 50 W), there was a significant difference in mean pressure gradient between the bovine and the porcine valves with labeled sizes 21 and 23, with superiority of the Perimount prosthesis. There was no difference in effective orifice area and incidence of patient-prosthesis mismatch among all sizes. The left ventricular mass index decreased significantly within 10 months postoperatively in the size 23 bovine group and the size 25 porcine group., Conclusions: Our data show a significant superiority of pressure gradients for the bovine bioprosthesis, especially with small valve sizes, when compared with the porcine device, which is more distinctive during exercise.

Background and Aim of the Study: The aim of this prospective, randomized study was to compare the hemodynamic performance of the Medtronic Mosaic and Edwards Perimount bioprostheses in the aortic position, and to evaluate prosthesis-specific differences in valve sizing and valve-size labeling., Methods: Between August 2000 and September 2002, 139 patients underwent isolated aortic valve replacement (AVR) with the Mosaic (n = 67) or Perimount (n = 72) bioprosthesis. Intraoperatively, the internal aortic annulus diameter was measured by insertion of a gauge (Hegar dilator), while prosthesis size was determined by using the original sizers. Transthoracic echocardiography was performed to determine hemodynamic and dimensional data. As the aim of AVR is to achieve a maximal effective orifice area (EOA) within a given aortic annulus, the ratio of EOA to patient aortic annulus area was calculated, the latter being based on annulus diameter measured intraoperatively., Results: Operative mortality was 2.2% (Mosaic 3.0%; Perimount 1.4%; p = NS). Upsizing (using a prosthesis larger in labeled valve size than the patient's measured internal aortic annulus diameter) was possible in 28.4% of Mosaic patients and 8.3% of Perimount patients. The postoperative mean systolic pressure gradient ranged from 10.5 to 22.2 mmHg in the Mosaic group, and from 9.4 to 12.6 mmHg in the Perimount group; it was significantly lower for 21 and 23 Perimount valves than for 21 and 23 Mosaic valves. The EOA ranged from 0.78 to 2.37 cm2 in Mosaic patients, and from 0.95 to 2.12 cm2 in Perimount patients. When indexing EOA by calculating the ratio of EOA to patient aortic annulus area to adjust for variables such as patient anatomy and valve dimensions, there was no significant difference between the two bioprostheses., Conclusion: Comparisons of absolute EOA values grouped by the manufacturers' valve sizes are misleading because of specific differences in geometric dimensions. The EOA:patient aortic annulus area ratio provides a new hemodynamic index which may facilitate objective comparisons between different valve types.

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