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Background: Transcatheter (TAVR) has supplanted surgical (SAVR) aortic valve replacement (AVR)., Aim: To evaluate whether adoption of this technology has varied according to centre volume at the nationwide level., Methods: From an administrative hospital-discharge database, we collected data on all AVRs performed in France between 2007 and 2019. Centres were divided into terciles based on the annual number of SAVRs performed in 2007-2009 ("before TAVR era")., Results: A total of 192,773 AVRs (134,662 SAVRs and 58,111 TAVRs) were performed in 47 centres. The annual number of AVRs and TAVRs increased significantly and linearly in low-volume (<152 SAVRs/year; median 106, interquartile range [IQR] 75-129), middle-volume (152-219 SAVRs/year; median 197, IQR 172-212) and high-volume (>219 SAVRs/year; median 303, IQR 268-513) terciles, but to a greater degree in the latter (+14, +16 and +24 AVRs/centre/year and +16, +19 and +31 TAVRs/centre/year, respectively; P ANCOVA <0.001). Charlson Comorbidity Index and in-hospital death rates declined from 2010 to 2019 in all terciles (all P trend <0.05). In 2017-2019, after adjusting for age, sex and Charlson Comorbidity Index, there was a trend toward lower death rates in the high-volume tercile (P=0.06) for SAVR, whereas death rates were similar for TAVR irrespective of tercile (P=0.27). Similar results were obtained when terciles were defined based on number of interventions performed in the last instead of the first 3years. Importantly, even centres in the lowest-volume tercile performed a relatively high number of interventions (150 TAVRs/year/centre)., Conclusions: In a centralized public healthcare system, the total number of AVRs increased linearly between 2007 and 2019, mostly due to an increase in TAVR, irrespective of centre volume. Progressive declines in patient risk profiles and death rates were observed in all terciles; in 2017-2019 death rates were similar in all terciles, although lower in high-volume centres for SAVR., (Copyright © 2024 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)

Background: There were gaps between guidelines and practice when surgery was the only treatment for aortic stenosis (AS)., Objectives: This study analyzed the decision to intervene in patients with severe AS in the EORP VHD (EURObservational Research Programme Valvular Heart Disease) II survey., Methods: Among 2,152 patients with severe AS, 1,271 patients with high-gradient AS who were symptomatic fulfilled a Class I recommendation for intervention according to the 2012 European Society of Cardiology guidelines; the primary end point was the decision for intervention., Results: A decision not to intervene was taken in 262 patients (20.6%). In multivariate analysis, the decision not to intervene was associated with older age (odds ratio [OR]: 1.34 per 10-year increase; 95% CI: 1.11 to 1.61; P = 0.002), New York Heart Association functional classes I and II versus III (OR: 1.63; 95% CI: 1.16 to 2.30; P = 0.005), higher age-adjusted Charlson comorbidity index (OR: 1.09 per 1-point increase; 95% CI: 1.01 to 1.17; P = 0.03), and a lower transaortic mean gradient (OR: 0.81 per 10-mm Hg decrease; 95% CI: 0.71 to 0.92; P < 0.001). During the study period, 346 patients (40.2%, median age 84 years, median EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 3.1%) underwent transcatheter intervention and 515 (59.8%, median age 69 years, median EuroSCORE II 1.5%) underwent surgery. A decision not to intervene versus intervention was associated with lower 6-month survival (87.4%; 95% CI: 82.0 to 91.3 vs 94.6%; 95% CI: 92.8 to 95.9; P < 0.001)., Conclusions: A decision not to intervene was taken in 1 in 5 patients with severe symptomatic AS despite a Class I recommendation for intervention and the decision was particularly associated with older age and combined comorbidities. Transcatheter intervention was extensively used in octogenarians., Competing Interests: Funding Support and Author Disclosures Since the start of EORP, the following companies have supported the program: Abbott Vascular Inc (2011-2021), Amgen Cardiovascular (2009-2018), AstraZeneca (2014-2021), Bayer AG (2009-2018), Boehringer Ingelheim (2009-2019), Boston Scientific (2009-2012), Bristol Myers Squibb–Pfizer Alliance (2011-2019), Daiichi-Sankyo Europe GmbH (2011-2020), Alliance Daiichi-Sankyo Europe GmbH and Eli Lilly and Company (2014-2017), Edwards (2016-2019), Gedeon Richter Plc (2014-2016), Menarini International Operations (2009-2012), MSD-Merck and Co (2011-2014), Novartis Pharma AG (2014-2020), ResMed (2014-2016), Sanofi (2009-2011), Servier (2009-2018), and Vifor (2019-2022). Dr Prendergast has received grants and personal fees from Edwards Lifesciences; has received personal fees from Abbott and Anteris outside the submitted work. Dr Wendler has received personal fees from Edwards Lifesciences and Neovasc during the conduct of the study. Dr Bax has received grants from Abbott, Edwards Lifesciences, Medtronic, Boston Scientific, Biotronik, GE Healthcare, and Bayer; and has received personal fees from Abbott during the conduct of the study. Dr Vahanian has received personal fees from Edwards Lifesciences, Medtronic, and Abbott Vascular during the conduct of the study; and has received personal fees from Edwards Lifesciences, Medtronic, Abbott Vascular, and Cardiovalve outside the submitted work. Dr Iung has received personal fees from Edwards Lifesciences; and has received travel fees from Boehringer Ingelheim outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Use of transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves in clinical practice is limited to patients with failing bioprostheses and rings or mitral valve disease associated with severe mitral annulus calcification. Whereas the use of valve-in-valve TMVR appears to be a reasonable alternative to surgery in patients at high surgical risk, much less evidence supports valve-in-ring and valve-in-mitral annulus calcification interventions. Data on the results of TMVR in these settings are derived from small case series or voluntary registries. This review summarizes the current evidence on TMVR using transcatheter aortic valves in clinical practice from the characteristics of the TMVR candidates, screening process, performance of the procedure, and description of current results and future perspectives. TMVR using dedicated devices in native noncalcified mitral valve diseases is beyond the scope of the article.

Background: Currently, there are no recommendations regarding the minimum duration of in-hospital monitoring after transfemoral (TF) transcatheter aortic valve replacement (TAVR) and practices are extremely heterogeneous. We, therefore, aimed to evaluate length of stay (LOS) and predictive factors for late discharge after TF TAVR using data from the FRANCE TAVI registry., Methods: TAVR was performed in 12,804 patients in 48 French centers between 2013 and 2015. LOS was evaluated in 5857 TF patients discharged home. LOS was calculated from TAVR procedure (day 0) to discharge. The study population was divided into three groups based on LOS values. Patients discharged within 3 days constituted the "very early" discharge group, patients with a LOS between 3 and 6 days constituted the "early" discharge group, and patients with a length of stay > 6 days constituted the "late" discharge group., Results: The median LOS was 7 (5-9) days and was extremely variable among centers. The proportion of patients discharged very early, early, and late was 4.4% (n = 256), 33.7% (n = 1997), and 61.9% (n = 3624) respectively. Variables associated with late discharge were female sex, co-morbidities, major complications, self-expandable valve, general anesthesia, and a significant center effect. In contrast, history of previous pacemaker was a protective factor. The composite of death and re-admission in the very early and early versus late discharge groups was similar at 30 days (3.3% vs. 3.5%, p = 0.66)., Conclusions: LOS is extremely variable after TF TAVR in France. Co-morbidities and complications were predictive factors of late discharge after TAVI. Interestingly, the use of self-expandable prosthesis and general anesthesia may also contribute to late discharge. Our results confirm that early discharge is safe.

Background: Complications decrease after transfemoral transcatheter aortic valve implantation (TAVI), and early discharge is feasible and safe in selected populations., Aims: To evaluate length of stay (LOS) and reasons for prolonged hospitalisation after transfemoral TAVI in unselected patients., Methods: Patients with severe aortic stenosis, who had transfemoral TAVI with the SAPIEN 3 prosthesis using exclusively local anaesthesia, were prospectively and consecutively included at five French high-volume centres. LOS was calculated from TAVI procedure to discharge. Reasons for prolonged hospitalisation (i.e.>3 days) were evaluated., Results: Between 2017 and 2018, 293 patients were included, with a mean age of 82.4±6.5 years and a mean logistic EuroSCORE of 13.7±9.0%. The in-hospital mortality rate was 1.4%. The median LOS was 5 (3-7) days, and varied considerably between centres (from 2 to 7 days). Sixty-four (21.8%) patients were discharged within 3 days after transfemoral TAVI. Reported reasons for prolonged hospitalisation were complications in 62.2%, loss of autonomy in 3.1%, discharge refusal in 2.2% and logistical reasons in 0.9%. In 31.6% of cases, the investigators reported no apparent reasons., Conclusions: The results of our study suggest that LOS after transfemoral TAVI, using the SAPIEN 3 prosthesis and a minimalist approach, varies considerably between centres. In almost a third of cases, hospitalisation was prolonged without any apparent reason. Efforts should be made to educate centres to reduce LOS., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Background: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access., Objectives: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR., Methods: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed., Results: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers., Conclusions: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI., Methods: Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment., Results: Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62-1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7-1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01-2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87-13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04-2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76-2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90-2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01-2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96-1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32-0.43; P < 0.001)., Conclusions: TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Despite the worldwide development of transcatheter aortic valve implantation (TAVI) over the last decade, strategies that take patient characteristics into account to guide the choice of transcatheter heart valve have not been evaluated., Aim: To evaluate the immediate results of TAVI using a tailored choice of balloon-expandable or self-expanding transcatheter heart valve, according to each patient's clinical and anatomical characteristics., Methods: This single-centre observational study included all patients treated with TAVI from 2012 to 2017. The 30-day results were reported according to Valve Academic Research Consortium-2 criteria. A total of 502 patients were included (mean age, 81±9 years; 52% men; mean EuroSCORE II, 7.0±6.5%). Three main variables guided the choice of transcatheter heart valve: the anatomy of the iliofemoral arteries and of the aortic root, and the general condition of the patient., Results: A SAPIEN™ balloon-expandable transcatheter heart valve was used in 275 patients (55%) and a CoreValve™ self-expanding transcatheter heart valve in 227 patients (45%). The approach was transfemoral in 427 patients (85%), and only 29 patients (6%) required transthoracic access. At 30-day follow-up, the rates of adverse events were as follows: mortality, 3.2%; stroke, 3.0%; major bleeding, 5.9%; and major vascular complications, 6.0%. Rates of complications at 30 days were similar in the SAPIEN™ and CoreValve™ groups, except for a higher rate of pacemaker implantation in the latter group (29.5% vs. 14.5%; P<0.001)., Conclusion: The choice of balloon-expandable or self-expanding transcatheter heart valve tailored to the patient's clinical and anatomical characteristics allows for maximal use of the transfemoral approach, and is associated with low 30-day rates of major complications and mortality., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Objective: In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR), the impact of concomitant mitral stenosis (MS) remains unknown. The aim of this study was to determine the incidence and impact of moderate to severe MS in patients undergoing TAVR., Methods: The study included 2113 consecutive patients (mean age: 80 ± 9 years, mean STS: 6.4 ± 5.2%) who underwent TAVR in 2 centers. The presence of MS was defined as a mean transmitral gradient ≥ 5 mm Hg on baseline echocardiography in the absence of severe mitral regurgitation. Clinical events were prospectively collected in a dedicated TAVR database., Results: A total of 157 patients (7.4%) had moderate to severe MS (mean gradient: 7.2 ± 2.8 mm Hg; degenerative origin in 88%). Patients with MS were younger, more frequently women, had a higher left ventricular ejection fraction and an increased rate of severe pulmonary hypertension (p < 0.02 for all). Thirty-day mortality was similar in both groups (MS: 3.8%; no MS: 5.5%, adjusted p = 0.34). At a mean follow-up of 3 ± 2 years, there were no differences between groups in mortality (MS: 35%, no MS: 36.2%, adjusted HR: 1.14, 95% CI: 0.86-1.51), or heart failure rehospitalization (MS: 21%, no MS: 21.7%; adjusted HR: 1.16, 95% CI: 0.81-1.67). Patients with MS exhibited a similar functional status at follow-up compared to those with no MS (NYHA I-II in 85% and 88% of patients, respectively, adjusted p = 0.20)., Conclusions: About 7% of patients undergoing TAVR had concomitant moderate to severe MS. The presence of MS had no negative impact on early and mid-term clinical outcomes post-TAVR. These results suggest that TAVR is a valid alternative for treating patients with aortic stenosis in the presence of moderate to severe MS., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves., Methods and Results: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses., Conclusions: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.

Objectives: This study sought to compare outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) in a catheterization laboratory (cath lab) to those undergoing TAVR in a hybrid operating room (OR)., Background: TAVR can be performed in a cath lab or in a hybrid OR. Comparisons between these locations are scarce., Methods: All TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. The primary endpoint of this study was all-cause mortality at 1 year. Secondary endpoints consisted of 30-day complications and 3-year mortality. All analyses were adjusted for baseline and procedural characteristics., Results: A total of 12,121 patients were included in this study, 62% of which underwent TAVR in a cath lab versus 38% in a hybrid OR. Mean age was 82.9 ± 7.2 years, 48.9% of patients were men, and mean Logistic EuroScore was 17.9% ± 12.3%. Both procedure locations showed similar, below 2% rates of intraprocedural complications. After adjusting for baseline and procedural characteristics, major bleeding and infections were significantly higher in the hybrid OR group (bleeding, 6.3% vs. 4.8%; infection, 6.1% vs. 3.5%; p < 0.05). Adjusted mortality rates at 1 and 3 years did not differ significantly between groups (for cath lab vs. hybrid OR, respectively: 1 year: 16.2% vs. 15.8%; p = 0.91; 3 years: 38.4% vs. 36.4%; p = 0.49)., Conclusions: Midterm mortality after TAVR was similar between the cath lab and the hybrid OR. These findings support the performance of TAVR in either location, which has important implications on health care organization and costs., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR)., Background: Since its development, aortic valve pre-dilatation has been an essential step of TAVR procedures. However, the feasibility of TAVR without systematic BAV has been described., Methods: TAVR performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (Registry of Aortic Valve Bioprostheses Established by Catheter) registry. We compared outcomes according to BAV during the TAVR procedure., Results: A total of 5,784 patients have been included in our analysis, corresponding to 2,579 (44.6%) with BAV avoidance and 3,205 (55.4%) patients with BAV performed. We observed a progressive decline in the use of BAV over time (78% of procedures in 2013 and 49% in the last trimester of 2015). Avoidance of BAV was associated with similar device implantation success (97.3% vs. 97.6%; p = 0.40). TAVR procedures without BAV were quicker (fluoroscopy 17.2 ± 9.1 vs. 18.5 ± 8.8 min; p < 0.01) and used lower amounts of contrast (131.5 ± 61.6 vs. 141.6 ± 61.5; p < 0.01) and radiation (608.9 ± 576.3 vs. 667.0 ± 631.3; p < 0.01). The rates of moderate to severe aortic regurgitation were lower with avoidance of BAV (8.3% vs. 12.2%; p < 0.01) and tamponade rates (1.5% vs. 2.3%; p = 0.04)., Conclusions: We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation., (Copyright © 2018 American College of Cardiology Foundation. All rights reserved.)

Background: Some patients who are at high surgical risk because of multiple co-morbidities undergo balloon aortic valvuloplasty (BAV) as a bridge therapy towards transcatheter aortic-valve implantation (TAVI)., Aim: The aim of this study was to compare the clinical course of patients with or without previous BAV who underwent TAVI and were included in the FRANCE 2 registry., Methods: From January 2010 to December 2011, 3953 patients underwent TAVI. Survival analysis was done by multivariable regression and propensity-score analysis to adjust for confounders., Results: Patients in the previous BAV group (n=664, 16.8%) were older than patients in the primary TAVI group. The logistic EuroSCORE I and the rates of co-morbidities and symptoms were higher in the previous BAV group. Procedural success was similar in both groups, as was postprocedural aortic regurgitation grade≥2/4. The 1-month mortality rates from all causes were 12.5 and 8.7%, respectively, in the previous BAV and primary TAVI groups (P=0.001). The 1-month to 1-year mortality rates were similar in both groups. Previous BAV was not an independent predictor of 1-month mortality (hazard ratio 1.44, 95% confidence interval 0.90-2.34; P=0.14) or 1-month to 1-year mortality., Conclusions: Crude 1-month mortality was higher in patients with previous BAV. Nevertheless, precarious preoperative status, but not previous BAV, was associated with mortality, and is the only marker that should be considered as detrimental at the time of preTAVI reassessment., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Efforts to develop and refine percutaneous approaches to cardiac valve repair and replacement have advanced rapidly over the past several years, having exceeded even the most optimistic expectations. New innovations have been predominantly directed toward the most frequent form of valvular heart disease (VHD) in the industrialized world; aortic stenosis (AS). Approximately 250,000 transcatheter aortic valve implantation (TAVI) procedures have been done so far addressing this significant medical need. Because of the predominance of degenerative etiologies, the prevalence of VHD increases markedly in population above the age of 65 years, in particular with regard to severe AS. As the populations of the industrialized countries continue to be older, the need for less invasive and safer methods of treating severe AS will continue to grow. In this review we provide comprehensive and up-to-date overview of TAVI in current clinical practice. We have also addressed dilemmas and unanswered questions related to TAVI procedures in different groups of patients and highlighted opportunities and trends related to future TAVI implementation., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

Aims: Our aim was to assess one-year outcomes of patients enrolled in the pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation (TAVI)., Methods and Results: One-year outcomes of 4,571 patients (81.4±7.2 years, 2,291 [50.1%] male) receiving TAVI with the SAPIEN XT (57.3%) or CoreValve prosthesis at 137 European centres were analysed using Kaplan-Meier and Cox proportional hazards regression techniques. At one year, 3,341 patients were alive, 821 had died, and 409 were lost to follow-up. Of 2,125 patients who underwent functional assessment, 1,916 (90%) were in New York Heart Association (NYHA) Class I/II at one year, with functional improvement from baseline noted in 1,682 patients (88%). One-year survival based on 4,564 patients was estimated at 79.1%. Independent baseline predictors of mortality were increasing age and logistic EuroSCORE, the presence of NYHA III/IV, chronic obstructive pulmonary disease, and atrial fibrillation. Female gender was associated with a 4% survival benefit at one year. Vascular access routes other than transfemoral were associated with poorer survival. Procedural failure and major periprocedural complications had an adverse impact on survival., Conclusions: Contemporary European experience attests to the effectiveness of routine TAVI in unselected elderly patients.

Calcific aortic stenosis (AS) is the most prevalent heart valve disorder in developed countries. It is characterized by progressive fibro-calcific remodelling and thickening of the aortic valve leaflets that, over years, evolve to cause severe obstruction to cardiac outflow. In developed countries, AS is the third-most frequent cardiovascular disease after coronary artery disease and systemic arterial hypertension, with a prevalence of 0.4% in the general population and 1.7% in the population >65 years old. Congenital abnormality (bicuspid valve) and older age are powerful risk factors for calcific AS. Metabolic syndrome and an elevated plasma level of lipoprotein(a) have also been associated with increased risk of calcific AS. The pathobiology of calcific AS is complex and involves genetic factors, lipoprotein deposition and oxidation, chronic inflammation, osteoblastic transition of cardiac valve interstitial cells and active leaflet calcification. Although no pharmacotherapy has proved to be effective in reducing the progression of AS, promising therapeutic targets include lipoprotein(a), the renin-angiotensin system, receptor activator of NF-κB ligand (RANKL; also known as TNFSF11) and ectonucleotidases. Currently, aortic valve replacement (AVR) remains the only effective treatment for severe AS. The diagnosis and staging of AS are based on the assessment of stenosis severity and left ventricular systolic function by Doppler echocardiography, and the presence of symptoms. The introduction of transcatheter AVR in the past decade has been a transformative therapeutic innovation for patients at high or prohibitive risk for surgical valve replacement, and this new technology might extend to lower-risk patients in the near future., Competing Interests: B.R.L. has received research support from and served on the scientific advisory board for Roche Diagnostics. B.I. has received consultant fees from Abbott and Boehringer Ingelheim and speaker’s fees from Edwards Lifesciences. P.P. has Core Lab contracts with Edwards Lifesciences, for which he receives no direct compensation, and is a speaker for St. Jude Medical. The other authors have no disclosure.

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., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The relationship between anemia, renal insufficiency, and the outcomes of TAVI patients has not been thoroughly studied. We aimed to evaluate the influence of pre- and post-procedural anemia on the incidence of renal insufficiency, especially AKI, and on the outcomes of TAVI., Methods: Data from the French national TAVI registry were collected in 3,472 patients who underwent TAVI between January 2010 and December 2012. Of these 2,137 were in the no/mild anemia group, 748 were in the moderate anemia group, and 587 were in the severe anemia group before TAVI. Furthermore, we divided the 3,472 patients into three groups according to post-procedural anemia, measured as post-procedural hemoglobin (Hb) drop: <2 g/dl (n=1,633, group 1), 2 to <4 g/dl (n=1,458, group 2), and >4 g/dl (n = 381, group 3). Procedure and outcome variables were compared., Results: Increased severity of anemia before TAVI was associated with significantly different rates of 1-year mortality (15%, 19%, and 24%, P<0.01), with similar differences in the incidence of AKI (5%, 8%, and 10%, P<0.01). Increased severity of Hb drop was associated with significantly different rates of 1-year mortality (16%, 18%, and 23%, P<0.01), and with similar differences in the incidence of AKI (6%, 7%, and 10%, P=0.04). Both pre- and post-procedural anemia were predictors of the incidence of AKI (OR 1.82, P<0.01; OR 1.82, P<0.01, respectively) and 1-year mortality (HR 1.44, P<0.01; HR 1.50, P<0.01, respectively)., Conclusions: Both pre- and post-procedural anemia were significantly associated AKI and 1-year mortality., (© 2015 Wiley Periodicals, Inc.)

Background: The prognostic value of previous pulmonary oedema (PO) has not been thoroughly investigated in a large-cohort of TAVI-patients. The aim of this study was to assess the influence of previous clinical history of acute PO in severe aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI)., Methods: Data were analyzed for 3195 patients enrolled in the French national TAVI registry, FRANCE 2. We compared the clinical outcome of enrolled patients divided broadly into three groups according to the frequency of previous acute PO episode; group 1: no-episode, group 2: single-episode, and group 3: multiple-episodes within the year preceding TAVI., Results: Of the 3195 patients (mean age: 82.7 ± 7.2 years, mean logistic-EuroSCORE: 21.8 ± 14.3) with TAVI, 1880 (58.8%) had no-episode, 937 (29.3%) had single-episode, and 378 (11.9%) had multiple-episode. Both 30-day and cumulative 1-year mortality increased significantly across the 3 groups (7.7% vs. 9.2% vs. 15.9%; p<0.001, 14.0% vs. 19.4% vs. 24.1%; p<0.001, respectively). In addition, single-PO was not independently associated with an increased mortality at 30-day and 1-year compared to no-PO (HR: 0.99; 95% CI: 0.75-1.30; p=0.923, HR: 1.15; 95% CI: 0.94-1.39; p=0.173, respectively). In contrast multiple-PO was independently associated with an increased risk of both 30-day and cumulative 1-year mortality (HR: 1.51; 95% CI: 1.10-2.01; p=0.012, HR: 1.30; 95% CI: 1.01-1.66; p=0.043, respectively)., Conclusion: Multiple-PO, but not single, within the year preceding the index procedure is independently associated with increased mortality at short- and mid-term follow up after TAVI., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Aims: The aim of this study was to assess the influence of chronic kidney disease (CKD) classification on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI)., Methods and Results: Data of 2,929 consecutive patients undergoing TAVI in the FRANCE 2 registry were analysed. Patients were divided into five groups: CKD 1+2, 3a, 3b, 4, and 5. Both 30-day and one-year mortality rates were significantly increased and positively correlated with CKD severity in all groups. After adjusting for significant influential confounders in a Cox regression multivariate model, CKD 4 and 5 were associated with increased risk of both 30-day mortality and one-year mortality when compared with CKD 1+2 as the reference. This higher mortality was predominantly driven by renal failure and infection in patients with CKD 4 and 5, respectively. Procedural success rate in CKD 5 was significantly lower than that in other groups. All CKD patients trended towards a higher incidence of acute kidney injury (AKI), in parallel with the degree of CKD severity., Conclusions: Classification of CKD stages before TAVI allows risk stratification for 30-day and one-year clinical outcomes. CKD 3b, 4 and 5 correlate with poor outcome and are considered a significant risk for TAVI.

The purposes of the present study were to determine the impact of chronic obstructive pulmonary disease (COPD) on Valve Academic Research Consortium-defined outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). A total of 3,933 consecutive patients underwent TAVI from January 2010 to December 2011 in 34 centers and were included in the French national TAVI registry "FRANCE 2"; 895 (22.7%) had concomitant COPD, 3,038 (77.3%) did not. There were no significant differences in procedural characteristics or 30-day Valve Academic Research Consortium-defined outcomes between those with and without COPD. Multivariate regression analysis showed COPD to be an independent predictor of 1-year mortality and combined efficacy end point after adjustment for concomitant co-morbidities (hazard ratio 1.19, 95% confidence interval 1.005 to 1.41, p = 0.03 and hazard ratio 1.52, 95% confidence interval 1.29 to 1.79, p <0.001, respectively). The higher mortality rate at 1 year in patients with COPD was related to cardiovascular deaths (COPD 10.0% vs non-COPD 6.2%, p = 0.008). Subgroup analysis found that the effect of COPD on 1-year mortality rate was constant across different subgroups, especially the type of approach and the type of anesthesia subgroups. In conclusion, concomitant COPD in patients referred for TAVI characterizes a high-risk population. The excess in mortality is largely determined by a higher rate of cardiovascular deaths and exists regardless of the type of procedure performed and its results., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Pulmonary hypertension (PH) is associated with poor prognosis in patients with severe aortic stenosis. The aim of this multicenter study was to describe clinical outcome after transcatheter aortic valve implantation., Methods and Results: The FRANCE 2 Registry included all patients undergoing transcatheter aortic valve implantation in France in 2010 and 2011. Patients were divided into 3 groups depending on systolic pulmonary artery pressure (sPAP) estimated in transthoracic echocardiography: group I, sPAP <40 mm Hg (no PH); group II, sPAP 40 to 59 mm Hg (mild-to-moderate PH); and group III, sPAP ≥60 mm Hg (severe PH). Patients were followed up for 1 year. A total of 2435 patients whose pre-transcatheter aortic valve implantation sPAP was reported were included. A total of 845 were in group I (34.7%), 1112 in group II (45.7%), and 478 in group III (19.6%). Procedural success, early complications, and 30-day mortality were statistically similar across sPAP groups. One-year mortality was higher in groups II and III (group I, 22%; group II, 28%; and group III, 28%; P=0.032). Mild-to-moderate and severe PH were identified as an independent factor of all-cause mortality. The major adverse cardiovascular event rates did not differ according to sPAP. New York Health Association functional class improved significantly in all groups., Conclusions: PH (sPAP ≥40 mm Hg) in patients with aortic stenosis undergoing transcatheter aortic valve implantation was associated with increased 1-year mortality especially when severe (sPAP ≥60 mm Hg) but not with increased 30-day mortality, and functional status was significantly improved regardless of PAP level.

Background: Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear., Methods and Results: TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1-Q3=178-490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P=0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery (P=0.04), larger aortic annulus (P=0.0004), and smaller prosthesis diameter (P=0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery(P=0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P=0.0001) and SE-TAVR (hazard ratio=2.11; P=0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR

Aortic stenosis (AS) is the consequence of active valve remodelling, which can be easily diagnosed, but for which no preventive strategy is available. It is the most common valve disease in Western countries, where its prevalence increases with age, reaching about 3% after the age of 75. The burden of AS is high and is expected to double within the next 50 years. Surgery is recommended in patients with severe symptomatic AS. In practice, however, surgery is often denied to the elderly owing to extensive comorbidities or 'frailty' and, as a consequence, decision-making is not always consistent with risk-benefit analysis. These findings highlight the need for less invasive approaches in high-risk patients and account for the rapid development of transcatheter aortic valve implantation (TAVI). Preliminary analyses suggest that in-hospital costs of TAVI compare favourably with the costs of surgery. Cost-effectiveness analyses are needed but should be interpreted with caution, given the discrepancies in analyses concerning surgery.

Little is known about transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve stenosis, which usually represents a contraindication. The aim of this study was to assess the feasibility and the results of TAVI in this patient subset. Of 316 high-risk patients with severe aortic stenosis who underwent TAVI from January 2009 to January 2012, 15 (5%) had documented bicuspid aortic valves. They were treated using a transarterial approach, using the Medtronic CoreValve system. Patients were aged 80 ± 10 years, in New York Heart Association functional classes III and IV. The mean aortic valve area was 0.8 ± 0.3 cm(2), and the mean gradient was 60 ± 19 mm Hg. The mean calcium score, calculated using multislice computed tomography, was 4,553 ± 1,872 arbitrary units. The procedure was successful in all but 1 patient. Major adverse events, according to Valvular Academic Research Consortium definitions, were encountered in 1 patient (death). The mean postimplantation prosthetic gradient was 11 ± 4 mm Hg, and ≤1+ periprosthetic leaks were observed in all but 2 patients. The mean prosthetic ellipticity index was 0.7 ± 0.2 at the level of the native annulus and 0.8 ± 0.2 at the level of the prosthetic leaflets. After a mean follow-up period of 8 ± 7 months, 1 patient had died from aortic dissection; there were no additional adverse events. All but 2 hospital survivors were in New York Heart Association class I or II. In conclusion, the present series suggests that transarterial Medtronic CoreValve implantation is feasible in selected patients with bicuspid aortic valve and may lead to short-term hemodynamic and clinical improvement., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Aortic valve stenosis progression rate is highly variable among patients and to date remains unpredictable. Evaluation of osteoblastic activity inside aortic valves may help identify patients with fast aortic stenosis progression rates and worse prognoses. Fluoride-18 sodium (FNa) is a clinically approved positron emission tomographic (PET) radiotracer with high and rapid bone uptake. The aim of this study was to test whether FNa accumulates in degenerative aortic valves and can be detected with PET imaging. Five patients with severe aortic stenosis and 10 patients free of aortic valvular calcium on computed tomography underwent PET imaging 40 minutes after the injection of 4 MBq/kg of FNa for oncologic or rheumatologic purposes. Maximal standard uptake values (SUVs) were measured retrospectively in aortic valves using PET imaging. Tissue-to-background ratios were calculated for each patient by dividing the maximal SUV measured in aortic valves by the mean SUV of blood. In patients with severe aortic stenosis, an intense accumulation of FNa was detected in aortic valve region on PET imaging, whereas only low activity was found in patients free of valvular calcification (median maximal SUV 2.6 g/ml/kg [interquartile range (IQR) 2.3 to 3.6] vs 2.0 g/ml/kg [IQR 1.7 to 2.2] and median tissue-to-background ratio 2.2 [IQR 2.0 to 2.7] vs 1.5 [IQR 1.5 to 1.7], respectively, p = 0.008 for both). Intraobserver variability for maximal SUV and tissue-to-background ratio in aortic valves was measured at 0.99 and interobserver variability at 0.98 and 0.97, respectively. In conclusion, in this pilot study, FNa accumulated in patients with severe aortic stenosis and could be quantified on PET imaging with good reproducibility. FNa PET imaging represents a promising imaging modality to evaluate osteoblastic activity inside calcified aortic valves., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI), introduced 10 years ago by Alain Cribier, has now been performed in more than 50,000 patients worldwide. Our vision of the main directions for the future are fourfold. Firstly, the 'Heart Team' is and will remain, essential for patient selection and the performance of the procedure. Careful training and controlled diffusion of the technique to medico-surgical centres are also keys to success. Secondly, patient selection must be refined, in order to predict the risk of surgery and that of TAVI. The technique is currently limited to very high-risk patients or those with contraindications to surgery. It will be extended to include lower risk patients once there are adequate trial data, the safety of the procedure has been improved and better knowledge of long-term outcomes from the procedure has been obtained. Thirdly, the procedure will be simplified, and should also be safer with an expected decrease in the occurrence of strokes, vascular complications and perivalvular regurgitation. Fourthly, the devices will also improve, with the addition of the potential for repositioning and improvement in durability. The role of imaging with the use of multimodality techniques will no doubt increase and ease the efficacy and safety of the procedure. Overall, the use of TAVI will undoubtedly increase over time, enabling a larger number of patients with severe aortic stenosis to be treated in an effective and safe way, in complement to surgical aortic valve replacement., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Objectives: Surgical aortic valve replacement in patients with previous coronary artery bypass grafting (CABG) carries a high mortality. Transcatheter aortic valve implantation (TAVI) has been shown to be successful in high risk subgroups of patients. Our goal is therefore to evaluate the impact of a history of CABG on the outcome of patients who undergo TAVI., Methods: From October 2006 to June 2010, among the 201 patients selected to undergo TAVI, 54 (27%) had a history of CABG. Outcomes were prospectively collected., Results: The 30-day outcome was not different between patients with previous CABG vs. those without, in particular as regards mortality (respectively, 5.6% vs. 10.9%; P = 0.25). Mid-term survival (mean FU: 7 ± 9 months) was not different at 2 years between patients with previous CABG vs. patients without (65.7 ± 6.2% vs. 80.0 ± 7.7% respectively; P = 0.12). In multivariate analysis, CABG was not associated with an excess mid-term mortality after TAVI., Conclusions: Previous CABG does not adversely affect outcome in patients undergoing TAVI. If confirmed by larger prospective series and ideally by a randomized trial comparing CABG vs. redo surgery, this observation might lead the heart team to consider TAVI as an attractive option in the population of high risk patients with aortic stenosis and previous CABG.

Background: Transcatheter aortic valve implantation (TAVI) is an alternative to conventional surgery in high-risk patients with severe aortic stenosis (AS), but data regarding mitral regurgitation (MR) characteristics and changes after TAVI are sparse., Methods: A total of 254 patients with severe AS referred for TAVI were prospectively enrolled. Comprehensive echocardiography was performed at baseline and at 7 days and 1 month in patients who underwent TAVI. MR was semiquantitatively graded from 0 to 4. Overlap of the anterior mitral leaflet and the device was measured using transesophageal echocardiography immediately after TAVI., Results: At screening, MR was absent in 26%, grade 1 in 44%, grade 2 in 25%, and grade ≥3 in 5% and was organic in 68% and functional in 32%. TAVI was finally performed using the Edwards Sapien valve in 119 patients, including four with MR grade ≥ 3. MR grade significantly decreased at 7 days (P = .003) but remained unchanged at 1 month (P = .55), whereas reverse remodeling occurred only at 1 month (improvements in left ventricular [LV] end-systolic diameter and ejection fraction; P < .05 for both). MR changes over time significantly differed according to ejection fraction and LV diameters (all P values for interaction < .005) but not according to aortic mean gradient, MR etiology, or overlap of the anterior mitral leaflet and the device (all P values for interaction > .15)., Conclusions: In patients referred for TAVI, MR is common, mainly organic, and rarely severe. After TAVI, MR improved within 7 days in both organic and functional MR, was not influenced by overlap of the anterior mitral leaflet and the device, but was associated with improvement in LV ejection fraction. Possible MR improvement should be taken into account in patient selection for TAVI especially, in cases of LV dysfunction or enlargement and MR of borderline severity., (Copyright © 2012 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.)

Aims: To assess the results of percutaneous aortic balloon valvuloplasty (PABV) as a potential bridge to further intervention in patients referred for transcatheter aortic valve implantation (TAVI)., Methods and Results: Two hundred and fifty-three patients referred for TAVI were studied: 41 (16%) were considered transiently unsuitable for either aortic valve replacement (AVR) or TAVI and underwent PABV as a bridge to intervention. In the others, primary TAVI or AVR was performed in 140 cases, and medical therapy alone in 72.The overall population was at high risk: 82 ± 8 years, logistic EuroSCORE: 28 ± 16%, STS score: 16 ± 10%. There was no PABV-related death. Twenty-three patients underwent secondary TAVI (n=19) or AVR (n=4), 18 did not undergo further intervention. One and two year survival rates were respectively 94 ± 5% and 85 ± 10% after bridge PABV, and 33 ± 11 and 6 ± 5% after PABV alone. There was no difference in survival between the primary TAVI / AVR and bridge PABV (p=0.08), and between medical treatment and PABV alone (p=0.36)., Conclusion: In high-risk patients with aortic stenosis and temporary contraindications to AVR or TAVI, PABV may be used as a bridge to intervention with good mid-term outcomes. In others, PABV can be safely used but is associated with a poor outcome.

Aims: Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis., Methods and Results: The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less., Conclusion: This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.

Background: Preoperative coronary angiography (CA) is recommended in patients with acute aortic valve infective endocarditis (AV-IE) and high cardiovascular risk profile but the level of evidence is low and its potential interest may be counterbalanced by the risk of dislodgement of vegetations and contrast-induced nephropathy., Objective: To review the use, indications and complication of preoperative CA in patients with AV-IE. Design Retrospective study., Patients: Consecutive series of 83 patients operated on for AV-IE between January 2002 and March 2007., Results: CA was performed in 36 (43%) patients, all but one as a preoperative test. Significant (>or=70%) lesions were observed in 10 patients and six underwent an associated coronary artery bypass graft. 47 patients were operated on without preoperative CA because of young age in 16 or recent CA in 13. Despite being theoretically indicated in all but one of the 18 remaining patients, CA was not performed because surgery as judged too urgent (eight patients) or valvular lesions were estimated as too important (10 patients). While the 35 patients with preoperative CA tended to be healthier (longer time to surgery and lower rate of urgent surgery), anatomical lesions were not different (rate of severe regurgitation, periannular complications and vegetation size, all p>0.20). No embolic event occurred after CA and preoperative CA was not associated with increased in-hospital mortality (p=0.80) or worsening renal function (p=0.93)., Conclusion: Preoperative CA can be performed at low risk in selected patients with AV-IE and should be considered before surgery in patients with cardiovascular risk factors. Our results support current guidelines.

Open in new tab Download slide OBJECTIVES This observational study aimed to evaluate Association pour l'Etude et la Prévention de l'Endocardite Infectieuse (AEPEI) surgery score predictive performance in comparison to general (EuroSCORE I, II) and specific (De Feo, PALSUSE) surgical risk scores for infective endocarditis (IE). METHODS The study included patients who underwent surgery for IE during the acute phase at Bichat University Hospital (Paris, France) between 1 January 2006 and 31 December 2016 and at Nancy University Hospital (Nancy, France) between 1 January 2009 and 31 December 2019. Patients with IE complicating percutaneous aortic valve implantations or implantable intra-cardiac devices were excluded. Discrimination and calibration were assessed using receiver operating characteristic curve analysis, calibration curves and the Hosmer–Lemeshow test. RESULTS In-hospital mortality rates were 18% at Bichat and 16% at Nancy. Discrimination was high for all risk scores at Bichat (area under the receiver operating characteristic curve = 0.77 for EuroSCORE I, 0.78 for EuroSCORE II, 0.76 for De Feo score, 0.72 for PALSUSE and 0.73 for AEPEI with 95% confidence interval ranging from 0.67 to 0.83), but lower at Nancy (0.56 for EuroSCORE I, 0.65 for EuroSCORE II, 0.63 for De Feo score, 0.67 for PALSUSE and 0.66 for AEPEI score with 95% confidence interval ranging from 0.47 to 0.75). With Brier score, all scores were adequately calibrated in both populations between 0.129 (De Feo) and 0.135 (PALSUSE) for Bichat and between 0.128 (De Feo) and 0.135 (EuroSCORE I) for Nancy. With the Hosmer–Lemeshow test, the AEPEI score exhibited the best calibration (observed/predicted ratio 1.058 in Bichat, 1.087 in Nancy). CONCLUSIONS This surgical score external validation in 2 large independent populations demonstrated that the AEPEI surgical score had the best predictive performance compared to other prognosis scores. It could be helpful in clinical practice to assist the endocarditis team in decision-making. [ABSTRACT FROM AUTHOR]

The article presents the discussion on valvular heart disease (VHD) in particular with an ageing population. Topics include publications addressing interventional treatment such as technical refinements and outcomes compared with surgery or medical therapy; and denosumab nor alendronic acid being shown to affect the progression of aortic valve calcification.

Transcatheter heart valve interventions have transformed the outcomes of patients with valvular heart disease (VHD) who are unfavourable candidates for surgery. Technological advances have allowed extension of these interventions to younger or lower risk patients and those with other forms of VHD and may in the future permit earlier treatment of VHD in less symptomatic patients or those with moderate disease. The balance of risks and benefits is likely to differ between lower and higher risk patients, and more evidence is needed to evaluate the net benefit of transcatheter technology in these groups. As academic researchers, clinicians, industry, and patient stakeholders collaborate to research these broader indications for transcatheter valve interventions, it is essential to address (i) device durability and deliverability, (ii) specific anatomical needs (e.g. bicuspid aortic valves, aortic regurgitation, mitral and tricuspid valve disease), (iii) operator training, and (iv) the reinforced importance of the multidisciplinary Heart Team. View large Download slide View large Download slide [ABSTRACT FROM AUTHOR]

Objective Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. Methods A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. Results TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age ≥90 years, body mass index <30 Kg/m², New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, ≥2 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. Conclusions Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients. [ABSTRACT FROM AUTHOR]

Objectives: The clinical and cost-saving benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis who are at high or intermediate risk of surgical mortality are supported by a growing evidence base. The PARTNER 3 trial (Placement of AoRTic TraNscathetER Valve Trial) demonstrated clinical benefits with SAPIEN 3 TAVI compared with SAVR in selected patients at low risk of surgical mortality. This study uses PARTNER 3 outcomes in combination with a French national hospital claim database to inform a cost-utility model and examine the cost implications of TAVI over SAVR in a low-risk population.Methods: A 2-stage cost-utility analysis was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured using the PARTNER 3 data set. These data fed into a Markov model that captured longer-term outcomes of patients, after TAVI or SAVR intervention.Results: TAVI with SAPIEN 3 offers meaningful benefits over SAVR in providing both cost saving (€12 742 per patient) and generating greater quality-adjusted life-years (0.89 per patient). These results are robust with TAVI with SAPIEN 3 remaining dominant across several scenarios and deterministic and probabilistic sensitivity analyses.Conclusions: This model demonstrated that TAVI with SAPIEN 3 was dominant compared with SAVR in the treatment of patients with severe symptomatic aortic stenosis who are at low risk of surgical mortality. These findings should help policy makers in developing informed approaches to intervention selection for this patient population. [ABSTRACT FROM AUTHOR]

Aims: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI). Methods and results: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform. Conclusion: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies. One-sentence summary: The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI. [ABSTRACT FROM AUTHOR]

Background: The optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Although dual antiplatelet therapy is recommended, single antiplatelet therapy or oral anticoagulation is frequently used according to the patient profile. Whether this approach may affect clinical outcome is unknown.Objectives: FRANCE TAVI (French Transcatheter Aortic Valve Implantation) is a prospective, multicenter, nationwide French registry. The study objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD), defined as increased prosthetic gradient ≥10 mm Hg or new gradient ≥20 mm Hg.Methods: To account for missing values, multiple imputations were performed. Stepwise multivariable Cox regression and logistic regression were used for all-cause mortality and bioprosthesis valve dysfunction was used, respectively. Sensitivity analysis retaining only patients with complete data were also performed.Results: Of 12,804 patients included in the registry between January 1, 2013, and December 31, 2015, a total of 11,469 (mean ± SE age: 82.8 ± 0.07 years; logistic European System for Cardiac Operative Risk Evaluation: 17.8 ± 0.1%; mean duration of follow-up: 495 ± 3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. A total of 2,555 patients had at least 2 echocardiographic evaluations and were eligible for BVD assessment. One-third of patients had a history of atrial fibrillation, and the same proportion had oral anticoagulation at discharge (n = 3,836). Neither aspirin nor clopidogrel was independently associated with mortality. Male sex (adjusted hazard ratio [aHR]: 1.63; 95% confidence interval [CI]: 1.44 to 1.84; p < 0.001), history of atrial fibrillation (aHR: 1.41; 95% CI: 1.23 to 1.62; p < 0.001), and chronic renal failure (aHR: 1.37; 95% CI: 1.23 to 1.53; p < 0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adjusted odds ratio [aOR]: 0.54; 95% CI: 0.35 to 0.82; p = 0.005) and a nonfemoral approach (aOR: 0.53; 95% CI: 0.28 to 1.02; p = 0.049) were independently associated with lower rates of BVD, whereas chronic renal failure (aOR: 1.46; 95% CI: 1.03 to 2.08; p = 0.034) and prosthesis size ≤23 mm (aOR: 3.43; 95% CI: 2.41 to 4.89; p < 0.001) yielded higher risk of BVD.Conclusions: Sex, renal failure, and atrial fibrillation affected mortality the most at the 3-year follow-up. In contrast, anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR. [ABSTRACT FROM AUTHOR]

Previous coronary artery bypass grafting (CABG) increases operative risk in conventional valve replacement. Transcatheter aortic valve implantation (TAVI) has been shown to be successful in high-risk patient subgroups. The present study compared outcome and overall survival in patients who underwent TAVI with and without history of CABG. From January 2010 to December 2011, 683 of the 3,761 patients selected for TAVI in 34 French centers (18%) had a history of CABG. Outcomes (mortality and complications) were collected prospectively according to the Valve Academic Research Consortium (VARC) criteria. Patients with previous CABG were younger, with higher rates of diabetes and vascular disease and higher logistic European System for Cardiac Operative Risk Evaluation (29.8 ± 16.4 vs 20.1 ± 13.0, p <0.001) but lower rates of pulmonary disease. Two types of valve (Edwards SAPIEN and Medtronic CoreValve) were implanted in equal proportions in the 2 groups. The 30-day and 1-year mortality rates from all causes on Kaplan-Meier analysis (9.2% vs 9.7%, p = 0.71; and 19.0% vs 20.2%, p = 0.49, respectively) did not differ according to the history of CABG. There were no significant differences in the Valve Academic Research Consortium complications (myocardial infarction, stroke or vascular, and bleeding complications). On multivariate analysis, CABG was not associated with greater 1-year post-TAVI mortality. In conclusion, previous CABG did not adversely affect outcome in patients who underwent TAVI, which may be an alternative to surgery in high-risk patients with severe aortic stenosis and history of CABG. [ABSTRACT FROM AUTHOR]