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Copyright of Archives of Cardiovascular Diseases is the property of Elsevier B.V. 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.)

Objectives The aim of this study was to determine baseline characteristics and clinical outcomes of patients with pre-existing atrial fibrillation (AF) and of patients who presented with new-onset AF after transcatheter aortic valve implantation (TAVI). Background Little is known regarding the impact of AF after TAVI. Methods The FRANCE-2 registry included all patients undergoing TAVI (N = 3,933) in France in 2010 and 2011. New-onset AF was defined as the occurrence of AF post-procedure in a patient with no documented history of AF. Results AF was documented before TAVI in 25.8% of patients. New-onset AF was observed in 174 patients after TAVI among patients without a history of pre-existing AF (6.0%). At 1 year, the rates of all-cause death (26.5 vs. 16.6%, respectively; p < 0.001) and cardiovascular death (11.5 vs. 7.8%, respectively; p < 0.001) were significantly higher in patients with pre-existing AF compared with those without AF. Rehospitalization for worsening heart failure and New York Heart Association functional class was also higher in patients with pre-existing AF versus those without, resulting in a higher rate of combined efficacy endpoint in this group (p < 0.001). A history of stroke, surgical (nontransfemoral) approach, cardiological, and hemorrhagic procedure-related events were all independently related to the occurrence of new-onset post-procedural AF. New-onset AF in patients without pre-existing AF was associated with a higher rate of combined safety endpoint at 30 days (p < 0.001) and a higher rate of both all-cause death and combined efficacy endpoint at 1 year (p = 0.003 and p = 0.02, respectively). Conclusions Pre-existing and new-onset AF are both associated with higher mortality and morbidity after TAVI. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to analyze the incidence, impact, and predictors of cerebrovascular events (CVEs) in patients undergoing transcatheter aortic valve replacement (TAVR). Background Several issues remain unresolved post-TAVR, including CVEs. Methods The FRANCE-2 (French Aortic Nation CoreValve and Edwards-2) registry prospectively included all patients who underwent TAVR in France and Monaco from January 2010 to October 2011. A total of 3,191 patients were analyzed. Six-month follow-up data were obtained. Events were adjudicated according to Valve Academic Research Consortium (VARC)-1 definition. Results Of the cohort, 3.98% experienced a CVE: 55% were major strokes, 14.5% minor strokes, and 30.5% transient ischemic attacks. The mean delay for CVE occurrence was 2 days (interquartile range: 0 to 7 days) with 48.5% of CVEs occurring within 2 days. There was no statistically significant difference in CVE rate with regard to the type of valve (p = 0.899) and the access route (p = 0.128). Patients with a CVE more frequently had new-onset paroxysmal atrial fibrillation (13.6% vs. 7.6%; p = 0.015). During follow-up, the unadjusted mortality rate was higher in patients with a CVE (26% vs. 16.5%; p = 0.002). By multivariate analysis, only advanced age (odds ratio: 1.05; 95% confidence interval: 1.02 to 1.08; p = 0.02) and having 2 valves implanted (odds ratio: 3.13; 95 confidence interval: 1.40 to 7.05; p = 0.006) were associated with a significant risk of CVEs. Conclusions CVEs occur frequently after TAVR and are associated with an increased mortality rate. No difference exists in the CVE rate when exploring the type of valve or the access route. Advanced age and multiple valves implanted during the same procedure are predictors of CVE. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve implantation (TAVI) performed under local anesthesia (LA) is becoming increasingly common. We aimed to compare the clinical outcomes in patients who underwent transfemoral-TAVI under general anesthesia (GA) and LA.Data from 2326 patients in the French Aortic National CoreValve and Edwards 2 (FRANCE 2) registry who underwent transfemoral-TAVI were analyzed. During the study period, the percentage of LA procedures increased gradually from 14% in January 2010 to 59% in October 2011. The clinical outcomes for GA (n=1377) and LA (n=949) were compared. Numerous baseline characteristics differed between the 2 groups, and the use of transesophageal echocardiographic guidance was more common in GA than in LA (76.3% versus 16.9%; P<0.001). Device success and cumulative 30-day survival rates were similar in the 2 groups (97.6% versus 97.0%; P=0.41 and 91.6% versus 91.3%; P=0.69, respectively), whereas the incidence of postprocedural aortic regurgitation≥mild was significantly lower in GA than in LA (15.0% versus 19.1%; P=0.015). The groups were also analyzed using a propensity-matching model, including transesophageal echocardiographic usage (GA [n=401] versus LA [n=401]). This model indicated that there were no significant differences between the 2 groups in the rates of 30-day survival (GA [91.4%] versus LA [89.3%]; P=0.27] and postprocedural aortic regurgitation≥mild (GA [12.7%] versus LA [16.2%]; P=0.19).The less invasive transfemoral-TAVI under LA is preferred in clinical settings and seems to be acceptable; however, the higher incidence of postprocedural aortic regurgitation is emphasized. Therapeutic efforts should be made to reduce such complications during transfemoral-TAVI under LA. [ABSTRACT FROM AUTHOR]

Background. Although transcatheter aortic valve implantation has been developing as an alternative treatment in elderly patients with high surgical risk, age-specific differences in clinical outcome have not been fully validated. Methods. Data were analyzed for 2,254 patients at least 80 years old who were enrolled between January 2010 and October 2011 in the French national transcatheter aortic valve implantation registry, FRANCE-2. Procedural and clinical outcomes defined according to the Valve Academic Research Consortium criteria were compared among subjects in three age groups: 80 to 84 years (n = 867), 85 to 89 years (n = 1,064), and at least 90 years (n = 349; range, 90 to 101 years). Results. The self-expandable prosthesis was implanted in 710 patients, and the balloon-expandable prosthesis was implanted in 1,544 patients. No differences were observed in rates of procedural success, Valve Academic Research Consortium-defined complications, and length of hospitalization among groups. Cumulative 30-day mortalities did not change among the three groups (80 to 84 years, 10.3% versus 85 to 89 years, 9.5% versus ≥90 years, 11.2%; p = 0.53). Cumulative 1-year mortalities also showed no statistical differences, although the mortality rate was higher in patients 85 to 89 years old and at least 90 years old compared with those 80 to 84 years old (19.8% versus 26.1% versus 27.7%; p = 0.16). After adjustment for differential baseline characteristics and potential confounders, patient age (85 to 89 years and ≥ 90 years compared with 80 to 84 years) was not associated with increasing risk of 30-day mortality (hazard ratio, 0.92, 1.26; 95% confidence interval, 0.66 to 1.27, 0.83 to 1.94; p = 0.38, 0.28, respectively) and 1-year mortality (hazard ratio, 1.16, 1.36; 95% confidence interval, 0.90 to 1.49, 0.97 to 1.89; p = 0.25, 0.073, respectively). Conclusions. This study revealed acceptable clinical results of transcatheter aortic valve implantation even in very elderly populations. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the accuracy, reproducibility, and predictive value for post-procedural aortic regurgitation (AR) of an automated multidetector computed tomography (MDCT) post-processing imaging software, 3mensio Valves (version 5.1.sp1, 3mensio Medical Imaging BV, the Netherlands), in the assessment of patients undergoing transcatheter aortic valve implantation (TAVI). Background: Accurate pre-operative aortic annulus measurements are crucial for patients undergoing TAVI. Methods: One hundred five patients undergoing MDCT screening before TAVI were evaluated. Aortic annular measurement was compared between automated 3mensio Valves software and manual data post-processing software on a dedicated workstation; we analyzed the discrimination value of annulus measurement for post-procedural AR in 44 recipients of a self-expanding valve. Results: The automated 3mensio Valves software showed good concordance with manual MDCT measurements as demonstrated by Bland-Altman analysis. The automated software provided equally good reproducibility as manual measurement, especially for measurement of aortic annulus area (intraobserver intraclass correlation coefficients 0.98 vs. 0.97, interobserver 0.98 vs. 0.95). In 44 patients after implantation of a self-expanding valve, the valve diameter/CT-measured geometric mean annulus diameter ratio by automated 3mensio Valves software showed moderate and better discrimination ability in predicting post-procedural AR compared with manual measurement (p = 0.12, area under the curve 0.77, 95% confidence interval: 0.63 to 0.91, area under the curve 0.68, 95% confidence interval: 0.50 to 0.86, respectively). Conclusions: The automated 3mensio Valves software demonstrated reliable, reproducible aortic annulus measurement and better predictive value for post-procedural AR, suggesting important clinical implications for pre-operative assessment of patients undergoing TAVI. [Copyright &y& Elsevier]

Bicuspid aortic valve (BAV) is regarded as a relative contraindication to transcatheter aortic valve implantation attributable to the risk of uneven expansion of the bioprosthesis. The purpose of this study was to evaluate the efficacy and safety of transcatheter aortic valve implantation in patients with BAV.Of 470 patients included in our prospective transcatheter aortic valve implantation database (October 2006-January 2012), 229 consecutive patients undergoing both echocardiography and multidetector computed tomography were analyzed. We compared clinical outcomes in patients with vs patients without BAV. In this series of 229 patients, BAV was detected by multidetector computed tomography in 21 patients (9.2%). BAV was identified by transthoracic and transoesophagal echocardiography in only 9 of these 21 patients. Patients were 83.1±6.6 years old, and European system for cardiac operative risk evaluation score was 20.0%±11.4%. The BAV group was similar to the non-BAV group except for diabetes mellitus (4.8% vs 24.0%; P=0.05). The aortic annulus diameter in BAV patients was not significantly larger by multidetector computed tomography (24.7±3.0 vs 23.7±1.9 mm; P=0.07). The CoreValve was used more frequently in the BAV group (47.6% vs 16.3%; P=0.002). There was no significant difference in device success (100% vs 92.8%; P=0.37), risk of annulus rupture (0% vs 1.4%; P=1.00), or valve migration (0% vs 1.4%; P=1.00) in BAV patients compared with non-BAV patients. Postprocedural mean gradient (10.0±3.4 vs 9.7±4.1 mm Hg; P=0.58), aortic regurgitation ≥2 of 4 (19.0% vs 14.9%; P=0.54), 30-day mortality (4.8% vs 8.2%; P=1.00), and 30-day combined safety end point (14.3% vs 13.5%; P=1.00) were also similar in both groups.In selected BAV patients, transcatheter aortic valve implantation may be associated with low complication rate, efficacy, and acceptable outcomes similar to those in non-BAV patients. [ABSTRACT FROM AUTHOR]

Copyright of Archives of Cardiovascular Diseases is the property of Elsevier B.V. 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.)

Objectives: The goal of the study was to clarify the impact of post-procedural aortic regurgitation (post-AR) grade 2/4 on clinical outcomes. Background: Post-AR >2/4 is known to be associated with poor short- to midterm outcome after transcatheter aortic valve implantation (TAVI). Methods: We compared clinical outcomes in 400 consecutive TAVI recipients according to post-AR grade: grade 0 or 1 (group 1 = 74.8%), grade 2 (group 2 = 22.2%), or grade 3 or 4 (group 3 = 3.0%). Results: The mean age was similar in the 3 groups (83.4 ± 6.1 years) as was the logistic EuroSCORE (22.5 ± 11.4%, 24.5 ± 11.6%, and 21.5 ± 9.4%, p = 0.28) and annulus size (22.0 ± 1.8, 22.2 ± 2.1, and 22.5 ± 2.1 mm, p = 0.53). The Edwards valve was most frequently used in group 1 compared with groups 2 and 3 (89.3%, 78.7%, and 83.3%, p = 0.03), and the implanted valve size was similar in all groups (25.6 ± 2.0, 25.4 ± 2.2, and 25.5 ± 2.2 mm, respectively, p = 0.69). Post-dilation was required more frequently in group 3 (4.7%, 24.1%, and 50.0%, respectively, p < 0.01). Post-procedural increase in mitral regurgitation was in line with the post-AR grade (0.78 ± 0.73, 1.22 ± 0.80, and 1.89 ± 0.78, respectively, p < 0.01). Despite the absence of difference in 30-day mortality, longer-term outcome was significantly poorer in patients with AR grade 2 than in those with AR grade 0 or 1 (log-rank p < 0.01), albeit better than in patients with AR grade 3 or 4 (p = 0.04), regardless of TAVI type and left ventricular function. Post-AR ≥2/4 was also identified as an independent predictor of mid- to long-term mortality (hazard ratio: 1.68, 95% confidence interval: 1.21 to 1.44, p < 0.01). Conclusions: Post-AR grade 2/4 after TAVI is associated with worse outcome compared with grade 0 or 1. Careful valve selection and post-dilation when required to avoid post-AR grade 2 may contribute to improved clinical outcome after TAVI. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to evaluate the incidence of vascular complications and the predictors of Prostar failure for a “true percutaneous approach” in transfemoral transcatheter aortic valve implantation (TAVI). Background: Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort. Methods: Among 264 patients included in our prospective TAVI database (October 2006 to December 2010), transfemoral-TAVI was performed in 170 patients. True percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar was defined as adequate hemostasis without Prostar-related vascular complications. We compared the incidence of vascular complications in our early and late experience. Results: Patients were 83.0 ± 7.2 years old and with a EuroSCORE of 24.0 ± 11.6%. The Edwards valve (Edwards Lifesciences, Irvine, California) (18- to 24-F) was used in 109 cases and the CoreValve (Medtronic, Minneapolis, Minnesota) (18-F) in 31. The sheath outer diameter to minimal femoral diameter ratio (SFAR) was 0.96 ± 0.14. Successful closure was achieved in 90.7%, and was significantly increased (95.7% vs. 85.7%, p = 0.047) in the late experience group. Cross-over to surgery was required in 3.6%. Vascular complications occurred in 20.0%, and were significantly lower in the late experience group (11.4% vs. 28.6%, p = 0.012). Major vascular complications (2.9% vs. 14.3%, p = 0.018) were decreased in the late experience group. Early experience (hazard ratio [HR]: 3.66, 95% confidence interval [CI]: 1.04 to 13.89, p = 0.047) and SFAR (HR: 110.80, 95% CI: 1.15 to 10,710.73, p = 0.044) predicted Prostar failure by univariate analysis. Conclusions: Experience reduced major vascular complications in a true percutaneous approach for transfemoral-TAVI. Further application of this less invasive strategy is feasible and may be beneficial, in this high-risk patient cohort. [Copyright &y& Elsevier]

Objectives: This study sought to evaluate the incidence, impact, and predictors of vascular complications in transcatheter aortic valve implantation (TAVI). Background: Vascular complications increase morbidity and mortality in transfemoral TAVI; however, there remains a paucity of data describing these serious events. Methods: We performed a prospective cohort study of 130 consecutive transfemoral TAVI recipients. Vascular complications were defined by the Valve Academic Research Consortium (VARC) criteria. The ratio of the sheath outer diameter (in millimeters) to the minimal femoral artery diameter (in millimeters) defined the sheath to femoral artery ratio (SFAR). Results: In our cohort of elderly patients (83.3 ± 5.9 years), the logistic EuroScore was 25.8% ± 11.9%. The Edwards valve was used in 102 cases (18- to 24-F) and the CoreValve in 27 (18-F). The minimal femoral artery diameter was 8.17 ± 1.14 mm, and the calcification (0 to 3) and tortuosity scores (0 to 3) were 0.58 ± 0.72 and 0.28 ± 0.53, respectively. The mean sheath diameter was 8.10 ± 0.82 mm, and the mean SFAR was 0.99 ± 0.16. Vascular complications occurred in 27.6% (VARC major: 17.3%, minor: 10.2%), and major vascular complications predicted 30-day mortality (22.7% vs. 7.6%, p = 0.049). The SFAR (hazard ratio [HR]: 186.20, 95% confidence interval [CI]: 4.41 to 7,855.11), center experience (HR: 3.66, 95% CI: 1.17 to 11.49), and femoral calcification (HR: 3.44, 95% CI: 1.16 to 10.17) predicted major complications by multivariate analysis. An SFAR threshold of 1.05 (area under the curve = 0.727) predicted a higher rate of VARC major complications (30.9% vs. 6.9%, p = 0.001) and 30-day mortality (18.2% vs. 4.2%, p = 0.016). Conclusions: Vascular complications in transfemoral TAVI are relatively frequent. VARC major vascular complications increase 30-day mortality and are predicted by experience, femoral calcification, and SFAR. Routine application of SFAR will improve patient selection for transfemoral TAVI and may improve outcome. [Copyright &y& Elsevier]

The security of civil aviation, like many human activities, is regulated by a series of international standards and recommended practices. The quality of these documents is a prerequisite to reach an acceptable security level. The EDEMOI project aims at investigating different techniques to analyse these standards. The techniques that we have used, such as Requirements Engineering (RE) and formal methods, have been fruitfully tried and tested in computer science. During the first step of the project, properties were extracted from standards written in natural language and a conceptual model of the underlying system was elaborated. Since none of the existing requirements engineering methods were able to consider the specifics of our project, we turned to situational method engineering, and have defined a new RE method based on this approach. The standard considered in the article is Annex 17 of the Convention of the International Civil Aviation Organization (ICAO). We present several adaptations/extensions to relevant RE techniques necessary to take into account the specific features of our project. Finally, we describe how we have applied this new method to the analysis of Annex 17. Copyright © 2006 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objective To clarify the impact of mild post-procedural aortic regurgitation (post-AR) on clinical outcomes. Background Post-procedural aortic regurgitation (post-AR) is known to be associated with poor short-mid term outcome after transcatheter aortic valve implantation (TAVI). Methods We compared clinical outcomes in 400 consecutive TAVI recipients according to post-AR grade: none (group 1=74.8%), mild (group 2=22.2%) or moderate to severe (group 3=3.0%). Results The mean age was similar in the 3 groups (83.4±6.1years) as well as logistic EuroSCORE (22.5±11.4, 24.5±11.6 and 21.5±9.4%, p=0.28) and annulus size (22.0±1.8, 22.2±2.1 and 22.5±2.1 mm, p=0.53). The Edwards valve was the most frequently used in group 1 compared to group 2 and 3 (89.3, 78.7 and 83.3%, p=0.03) and the implanted valve size was similar in all groups (25.6±2.0, 25.4±2.2 and 25.5±2.2 mm respectively, p=0.69). Post-dilatation was required more frequently in group 3 (4.7, 24.1 and 50.0% respectively, p<0.01). Post-procedural increase in mitral regurgitation was in line with the post-AR grade (0.78±0.73, 1.22±0.80 and 1.89±0.78, respectively, p<0.01). Despite the absence of difference in 30-day mortality, longer-term outcome showed patients with mild AR had a significantly worse outcome compared to none (log-rank p<0.01) and better than moderate to severe (p=0.04), regardless of TAVI type and left ventricular function. Post-AR was also identified as an independent predictor for mid-long term mortality (HR1.68, 95%CI:1.21–1.44, p<0.01). Conclusion Mild post-AR after TAVI is associated with worse outcome compared to none to trivial. Cautious valve selection and post-dilatation when required to avoid mild post-AR might contribute to improved clinical outcome after TAVI. [ABSTRACT FROM AUTHOR]

Objectives The purpose of this study was to evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) in patients with small body size (SB). Background Clinical outcome of TAVI in patients with SB remains unclear. Methods Between October 2006 and November 2011, 424 patients with severe aortic stenosis undergoing TAVI were evaluated. The cohort with small body surface area of <1.75 m² was defined as the "SB group" (n=215) and the rest of the cohort with large body-size as the "LB group" (n=209). Results In the SB group, the aortic annulus and femoral artery diameter were significantly smaller (23.0±1.86 vs 24.3±1.94 mm, p <0.001; 7.59±1.06 vs 8.29±1.34 mm, p <0.001, respectively). The logistic EuroSCORE was similar between the groups (22.5±10.4 vs 23.4±12.0, p=0.433). Equivalent device success (91.2 vs 91.4%, p=0.935) and 30-day survival rates (85.1 vs 87.6%, p=0.464) were achieved in both groups. Vascular complications were significantly higher in the SB group (13.0% vs 4.3%, p=0.002). Similar post-procedural mean pressure gradient was achieved in both groups (10.2±4.3 vs 11.0±4.6 mmHg, p=0.119). Kaplain-Meier survival analysis revealed no significant difference in the mid-term survival between groups (log-rank p=0.642). Conclusions TAVI in patients with SB resulted in similar clinical outcomes with effective post-procedural hemodynamics compared with LB. Care should be taken to avoid vascular complication in patients with SB. [ABSTRACT FROM AUTHOR]

Mean Gradient (MG) elevation can be detected immediately after transcatheter aortic valve implantation (TAVI) or secondarily during follow-up. Comparisons and interactions between these two parameters and their impact on outcomes have not previously been investigated. This study aimed to identify incidence, influence on prognosis, and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (6 to 12 months after TAVI, DMGI) in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. The registry includes all consecutive symptomatic patients with severe aortic stenosis who have undergone TAVI. Three groups were analyzed: (1) PPMG < 20 mmHg without DMGI > 10 mmHg (control); (2) PPMG < 20 mmHg with DMGI > 10 mmHg (Group 1); and (3) PPMG ≥ 20 mmHg (Group 2). From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. Controls comprised 2078 patients. In Group 1( n = 131 patients), DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-years mortality than in controls (32.6% vs. 40.1%, p = 0.27). In Group 2 ( n = 144 patients), PPMG was at least 20 mmHg in 6.1% and was associated with higher 4-year mortality (48.7% versus 40.1%, p = 0.005). A total of two-thirds of the patients with PPMG ≥ 20 mmHg had MG < 20 mmHg at 1 year, with mortality similar to the controls (39.2% vs. 40.1%, p = 0.73). Patients with PPMG > 20 mmHg 1 year post-TAVI had higher 4-years mortality than the general population of the registry, unlike patients with MG normalization.

Aim: To obtain a quantitative expression profile of the main genes involved in the cAMP-signaling cascade in human control atria and in different cardiac pathologies., Methods and Results: Expression of 48 target genes playing a relevant role in the cAMP-signaling cascade was assessed by RT-qPCR. 113 samples were obtained from right atrial appendages (RAA) of patients in sinus rhythm (SR) with or without atrium dilation, paroxysmal atrial fibrillation (AF), persistent AF or heart failure (HF); and left atrial appendages (LAA) from patients in SR or with AF. Our results show that right and left atrial appendages in donor hearts or from SR patients have similar expression values except for AC7 and PDE2A. Despite the enormous chamber-dependent variability in the gene-expression changes between pathologies, several distinguishable patterns could be identified. PDE8A, PI3Kγ and EPAC2 were upregulated in AF. Different phosphodiesterase (PDE) families showed specific pathology-dependent changes., Conclusion: By comparing mRNA-expression patterns of the cAMP-signaling cascade related genes in right and left atrial appendages of human hearts and across different pathologies, we show that 1) gene expression is not significantly affected by cardioplegic solution content, 2) it is appropriate to use SR atrial samples as controls, and 3) many genes in the cAMP-signaling cascade are affected in AF and HF but only few of them appear to be chamber (right or left) specific., Topic: Genetic changes in human diseased atria., Translational Perspective: The cyclic AMP signaling pathway is important for atrial function. However, expression patterns of the genes involved in the atria of healthy and diseased hearts are still unclear. We give here a general overview of how different pathologies affect the expression of key genes in the cAMP signaling pathway in human right and left atria appendages. Our study may help identifying new genes of interest as potential therapeutic targets or clinical biomarkers for these pathologies and could serve as a guide in future gene therapy studies., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Objectives: Transcatheter aortic valve implantation with a transaortic approach (TAo-TAVI) is an alternative to transapical or femoral access. We studied the procedural and midterm efficacy and safety of TAo-TAVI with Edwards Sapien XT and Medtronic CoreValve devices., Methods: Among 901 patients receiving TAVI since 2006, 265 consecutive patients underwent TAo-TAVI between January 2011 and September 2014. Procedural and midterm results were evaluated according to Valve Academic Research Consortium-2 criteria., Results: The mean age was 83 ± 5 years. Sapien XT and CoreValve were used in 191 (72.1%) and 74 (27.9%) patients, respectively. Full sternotomy made elective concomitant off-pump coronary artery bypass grafting possible in 38 patients (14.3%) with severe coronary artery disease unsuitable for percutaneous coronary intervention. The device success rate was 95.5%. Postprocedural paravalvular leak  ≥2/4 was observed in 16 patients (6.4%). Emergency open chest surgery was required in 10 patients (3.8%) (3 aortic dissections, 3 valve embolizations, 2 LMCA occlusions, 1 aortic annulus rupture and 1 aortic rupture). Cerebrovascular accidents occurred in 3 patients (1.1%). Transfusions  ≥4 units were required in 36 patients (13.6%). New pacemakers were implanted in 26 patients (9.8%). Thirty-day and 1-year mortality were 8.7% and 16.2%, respectively. Mean follow-up duration was 24 ± 6 months. At 3 years, freedom from all-cause death was 80% ± 4%. New York Heart Association class

Aims: Quantitative real-time RT-PCR (RT-qPCR) has become the method of choice for mRNA quantification, but requires an accurate normalization based on the use of reference genes showing invariant expression across various pathological conditions. Only few data exist on appropriate reference genes for the human heart. The objective of this study was to determine a set of suitable reference genes in human atrial and ventricular tissues, from right and left cavities in control and in cardiac diseases., Methods and Results: We assessed the expression of 16 reference genes (ACTB, B2M, GAPDH, GUSB, HMBS, HPRT1, IPO8, PGK1, POLR2A, PPIA, RPLP0, TBP, TFRC, UBC, YWHAZ, 18S) in tissues from: right and left ventricles from healthy controls and heart failure (HF) patients; right-atrial tissue from patients in sinus rhythm with (SRd) or without (SRnd) atrial dilatation, patients with paroxysmal (pAF) or chronic (cAF) atrial fibrillation or with HF; and left-atrial tissue from patients in SR or cAF. Consensual analysis (by geNorm and Normfinder algorithms, BestKeeper software tool and comparative delta-Ct method) of the variability scores obtained for each reference gene expression shows that the most stably expressed genes are: GAPDH, GUSB, IPO8, POLR2A, and YWHAZ when comparing either right and left ventricle or ventricle from healthy controls and HF patients; GAPDH, IPO8, POLR2A, PPIA, and RPLP0 when comparing either right and left atrium or right atria from all pathological groups. ACTB, TBP, TFRC, and 18S genes were identified as the least stable., Conclusions: The overall most stable reference genes across different heart cavities and disease conditions were GAPDH, IPO8, POLR2A and PPIA. YWHAZ or GUSB could be added to this set for some specific experiments. This study should provide useful guidelines for reference gene selection in RT-qPCR studies in human heart., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.)

Background: Coronary artery disease (CAD) is common in patients undergoing transcatheter aortic valve replacement (TAVR). However, the impact of CAD distribution before TAVR on short- and long-term prognosis remains unclear., Hypothesis: We hypothesized that the long-term clinical impact differs according to CAD distribution in patients undergoing TAVR using the FRench Aortic National CoreValve and Edwards (FRANCE-2) registry., Methods: FRANCE-2 is a national French registry including all consecutive TAVR performed between 2010 and 2012 in 34 centers. Three-year mortality was assessed in relation to CAD status. CAD was defined as at least 1 coronary stenosis >50%., Results: A total of 4201 patients were enrolled in the registry. For the present analysis, we excluded patients with a history of coronary artery bypass. CAD was reported in 1252 patients (30%). Half of the patients presented with coronary multivessel disease. CAD extent was associated with an increase in cardiovascular risk profile and in logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (from 19.3% ± 12.8% to 21.9% ± 13.5%, P < 0.001). Mortality at 30 days and 3 years was 9% and 44%, respectively, in the overall population. In multivariate analyses, neither the presence nor the extent of CAD was associated with mortality at 3 years (presence of CAD, hazard ratio [HR]: 0.90; 95% confidence interval [CI]: 0.78-1.07). A significant lesion of the left anterior descending (LAD) was associated with higher 3-year mortality (HR: 1.42; 95% CI: 1.10-1.87)., Conclusions: CAD is not associated with decreased short- and long-term survival in patients undergoing TAVR. The potential deleterious effect of LAD disease on long-term survival and the need for revascularization before or at the time of TAVR should be validated in a randomized control trial., (© 2017 Wiley Periodicals, Inc.)

Background: Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up., Objectives: This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry., Methods: The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used., Results: A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up., Conclusions: The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The development of new onset atrial fibrillation (NOAF) post-transcatheter aortic valve implantation (TAVI) is common and may be associated with an adverse prognosis. This study seeks to identify incidence, predictors, and impact of NOAF post-TAVI., Methods: From the multicenter study of the French national transcatheter aortic valve implantation registry, FRANCE 2, a total of 1959 patients with sinus rhythm prior to TAVI were enrolled into this study. The incidence of post-TAVI NOAF, predictors of development of NOAF and impact on 30-day and 1-year-mortalities were assessed., Results: Of the 1959 TAVI patients (mean-age: 82.6 ± 7.5 years, mean-logistic-EuroSCORE: 21.8 ± 14.3), 149 (7.6%) developed NOAF with the remaining 1810 (92.4%) control patients demonstrating no evidence of AF as defined by the Valve Academic Research Consortium (VARC). Advanced age and major and life-threatening bleeding were independent predictors of NOAF (95% CI: 0.93-0.99; p=0.006, 95% CI: 1.58-4.00; p<0.001, 95% CI: 1.09-3.75; p=0.025, respectively). A trend towards a higher incidence of major and life-threatening bleeding was observed in the patients undergoing TAVI via the transapical (TA)-approach compared with the transfemoral (TF)-approach. Both 30-day and cumulative 1-year-mortalities were significantly higher in patients with NOAF compared to patients without NOAF (3.0% vs. 7.4%; p=0.005, 9.1% vs. 20.8%; p<0.001, respectively). In addition, NOAF was an independent predictor of 30-day and 1-year-mortalities (HR: 2.16; 95% CI: 1.06-4.41; p=0.033, HR: 2.12; 95% CI: 1.42-3.15; p<0.001, respectively)., Conclusion: Advanced age and major and life-threatening bleeding were independently associated with increased incidence of NOAF, which itself was an independent predictor of 30-day and 1-year-mortalities. With regards to the various transcatheter approaches, a trend towards a higher incidence of major and life-threatening bleeding was observed only with the TA-approach., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Few data are available about whether aortic root calcification may impact the outcomes after transcatheter aortic valve implantation (TAVI)., Objectives: This study sought to evaluate the impact of aortic root calcification volume on clinical outcome after TAVI with balloon expandable Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California)., Methods: A total of 162 TAVI patients (aged 84.0 [Interquartile Range (IQR) 81.0-84.0] years, Logistic EuroSCORE 14.5 [IQR 9.8-25.1]) with preprocedural MDCT were studied. Aortic root calcification volume was measured by MDCT image and using the dedicated software for aortic valve assessment (the automated 3mensio™ Valves 5.1, sp1, 3mensio Pie Medical Imaging BV, Maastricht, the Netherlands). A valve calcification index (VCI) was defined as calcification volume (mm(3))/body surface area (mm(2))., Results: VCI was significantly higher among patients with 30-day mortality. A VCI threshold of 517.4 (area under the curve 0.69, 95% CI 0.50-0.87, P = 0.03) predicted a higher incidence of annulus rupture (9.1 vs. 0.9%, P = 0.02) and cardiac tamponade (12.7 vs. 1.9%, P < 0.01), lower device success (83.6% vs. 95.3%, P < 0.01) and 30-day survival rate (80.0% vs. 97.2%, P < 0.01). Multivariate logistic regression analysis showed only ejection fraction and VCI were identified as independent predictors of 30-day mortality (Odds ratio 0.948 [95% confidence interval 0.909-0.988], P = 0.012, Odds ratio 1.003 [95% confidence interval 1.001-1.005], P = 0.013, respectively)., Conclusions: Significantly worse acute clinical outcomes after Edwards valve implantation were observed in patients with large amount of aortic annulus calcifications quantitatively measured by dedicated MDCT software. Application of VCI may prove helpful in prediction of clinical outcomes after TAVI., (© 2015 Wiley Periodicals, Inc.)