Femoral Versus Nonfemoral Peripheral Access for Transcatheter Aortic Valve Replacement.

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.

Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry.

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.

Prognostic value of new onset atrial fibrillation after transcatheter aortic valve implantation: A FRANCE 2 registry substudy.

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.

Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel.

OBJECTIVES: After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS: Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS: Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION: The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.

Fate of aortic bioprostheses: An 18-year experience.

OBJECTIVE: To report our experience in aortic valve replacement with the Mitroflow (Sorin, Vancouver, Canada) aortic bioprosthesis. METHODS: We retrospectively reviewed all patients who underwent aortic valve replacement with a Mitroflow bioprosthesis at our institution from January 1994 to December 2011. No exclusion criteria were retained. Patients were followed yearly. Echocardiography follow-up was performed systematically before the hospital discharge and annually by patients' cardiologists. RESULTS: Seven hundred twenty-eight patients (mean age, 76 ± 6 years; range, 33-91 years) underwent aortic valve replacement with Mitroflow 12A or LX model and were included in this analysis. 30-day mortality for nonemergent isolated aortic valve replacement was 5.5%. Eight patients (1%) underwent reoperation for structural valve deterioration (SVD) and 30 patients (5.8%) presented echocardiographic signs of SVD. Actuarial freedom from reoperation for SVD was 99% ± 0.5% and 95% ± 5% at 10 and 15 years. Actuarial freedom from echocardiographic signs of SVD was 77% ± 5% and 56% ± 11% at 10 and 15 years, respectively. At the univariate analysis, only the mean gradient at discharge (P = .0200), the prevalence of size 19 (P = .0273), and severe patient-prosthesis mismatch (P = .0384) were significantly different in patients developing SVD at follow-up. Freedom from echocardiographic signs of SVD at 8 years were 88% ± 4% and 64% ± 13% in patients with a Mitroflow > 19 and Mitroflow 19, respectively (log-rank test, P = .0056; Wilcoxon test, P = .0589). CONCLUSIONS: Overall outcomes were satisfactory. However the risk of early SVD seems higher for the Mitroflow size 19. This size should be reserved for applications when annulus enlargement is risky or there is an anatomic contraindication to sutureless or stentless valve.

Baseline Characteristics and Prognostic Implications of Pre-Existing and New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: Results From the FRANCE-2 Registry.

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.

[From FRANCE 2 to FRANCE TAVI: are indications, technique and results of transcatheter aortic valve replacement the same?]. / De FRANCE 2 à FRANCE TAVI: les indications, la technique et les résultats du remplacement valvulaire aortique percutané sont-ils les mêmes?

Transcatheter aortic valve implantation (TAVI) is indicated in patients with severe symptomatic aortic stenosis who are not suitable for surgery or should be considered when there is a high surgical risk as assessed by a heart team. There is a decrease in mean logistic EuroSCORE since January 2010, which translates a gradual evolution in patients' selection. Expertise of geriatricians to further assess frailty is a key step in the risk stratification process of this elderly population (mean age: 83.4±7.3 years). Femoral access is used in 80% of cases with a procedural success rate higher than 95%. In-hospital mortality rate is 5.9%. The main complications of the procedure are aortic annulus rupture (0.9% in FRANCE TAVI), tamponade (2.3%), stroke (2.2%), severe paravalvular leak (1.3%) and permanent pacemaker implantation (15%). The awaited results of PARTNER II and SURTAVI may lead to expand the indications to lower-risk patients if it is shown that TAVI is non-inferior to surgery in this population which has been suggested by the recent randomized NOTION Trial while the CoreValve Pivotal Trial even points in the direction of a possible superiority of the percutaneous technique over surgery.

Comparison of Outcome of Transcatheter Aortic Valve Implantation With Versus Without Previous Coronary Artery Bypass Grafting (from the FRANCE 2 Registry).

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.

Prognosis importance of low flow in aortic stenosis with preserved LVEF.

AIMS: Previous studies using echocardiography suggested that a low flow (LF) defined as an indexed stroke volume (SVi) <35 mL/m(2) may be an important determinant of outcome in patients with severe aortic stenosis (AS). We sought to assess the prognostic importance of stroke volume derived from invasive data. The aim of this study was to determine the impact of LF, purposely derived from cardiac catheterisation data, on outcome of patients with severe AS and preserved LVEF. METHODS: Between 2000 and 2010, 768 patients with preserved LVEF (>50%) and severe AS (valve area ≤1 cm(2)) without other valvular heart disease underwent cardiac catheterisation. The long-term overall mortality was assessed as the primary end-point. RESULTS: Mean age was 74±8 years, 58% were men, 46% had coronary artery disease and mean LVEF was 72±10%. Low SVi was found in 27% (n=210) of patients with AS. As compared with patients with normal SVi, those with low SVi were significantly older (p<0.0001) with higher rate of atrial fibrillation (p<0.0001). Additionally, they had lower LVEF (p=0.046), aortic valve area (p<0.0001), mean pressure gradient (p<0.0001), systemic arterial compliance (p<0.0001) and higher systemic vascular resistances (p<0.0001). Eight-year survival was significantly reduced in patients with low SVi as compared with those with normal SVi (51±5% vs 67±3%; p<0.0001). After adjustment for all other risk factors, reduced SVi was independently associated with long-term mortality (HR=1.45, 95% CI 1.1 to 2.1; p=0.048). CONCLUSIONS: In patients with severe AS and preserved LVEF, LF, as assessed using cardiac catheterisation is frequent, and is an independent predictor of mortality. Consequently, the measurement of SVi should be systematically included in the assessment of these patients.

Comparison of outcomes after one-versus-two transcatheter aortic valve implantation during a same procedure (from the FRANCE2 Registry).

Analysis of the causes, outcomes, and mortality of patients with severe symptomatic aortic stenosis requiring the implantation of 2 valves during transcatheter aortic valve implantation was conducted from the French Aortic National CoreValve and Edwards 2 (FRANCE2) registry. Pre- and postprocedural data from 3,919 patients from January 2010 to December 2011 (CoreValve or Edwards) were collated and analyzed. Characteristics of patients requiring immediate second valve procedures were compared with those of the other patients. The 72 patients (1.8%) who underwent implantation of a second valve were studied. Indications were device malpositioning (72%) and embolization (28%). Clinical and echocardiographic characteristics of patients receiving 2 valves were comparable with those of the other patients. The 2-year survival rate was 51.7% for patients with 2 valves as opposed to 62.3% for those with 1 valve (p<0.001). The need for a second valve was an independent predictor of all-cause (hazard ratio 2.32, 95% confidence interval 1.50 to 3.60, p<0.001) and cardiovascular (hazard ratio 2.64, 95% confidence interval 1.35 to 5.15, p<0.001) mortality at 2 years. During follow-up, clinical and echocardiographic data remained similar between the 2 groups. In conclusion, in the FRANCE2 study, the main causes for second valve implantation during the same procedure were malpositioning and embolization. Although the procedure was feasible, it was accompanied by excess mortality. Valve hemodynamic status was preserved during the course of follow-up.

Impact of pre- and post-procedural anemia on the incidence of acute kidney injury and 1-year mortality in patients undergoing transcatheter aortic valve implantation (from the French Aortic National CoreValve and Edwards 2 [FRANCE 2] Registry).

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.

Impact of previous acute pulmonary oedema after transcatheter aortic valve implantation: insight from French Aortic National CoreValve and Edwards 2 [FRANCE 2]registry.

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.

Outcomes following pacemaker implantation after transcatheter aortic valve implantation with CoreValve(®) devices: Results from the FRANCE 2 Registry.

AIMS: Permanent pacemaker (PPM) implantation following high-degree atrioventricular block is frequently required after transcatheter aortic valve implantation (TAVI) using CoreValve(®) . Recent improvement of the delivery system (CoreValve Accutrak(®) ) aimed to ease delivery and reduce the PPM rate. Our study evaluated the incidences of PPM implantation following use of CoreValve(®) or CoreValve Accutrak(®) and the clinical outcome of these patients. METHODS AND RESULTS: A total of 883 patients (82 ± 7 years; 41.3% female) with severe symptomatic aortic stenosis and self-expanding bioprosthesis implantation were included between January 2010 and October 2011 in 29 centers from the FRANCE 2 Registry. Follow-up data were available in 833 patients. CoreValve(®) and CoreValve Accutrak(®) were used in 343 (41.2%) and 490 (58.8%) patients, respectively. During a mean follow-up of 242 ± 179 days, all-cause mortality was similar in patients with versus without PPM implantation (16.3 vs. 16.9%, P = 0.832).There was no significant difference in the PPM incidence in CoreValve(®) and CoreValve Accutrak(®) patients (30.4% vs. 27.5%, P = 0.846). CONCLUSION: PPM implantation remained frequent after TAVI using CoreValve Accutrak(®) . All-cause mortality was similar in patients with or without PPM implantation. The new device failed to show a significant decrease in PPM implantation incidence after TAVI. © 2015 Wiley Periodicals, Inc.

Impact of chronic kidney disease on the outcomes of transcatheter aortic valve implantation: results from the FRANCE 2 registry.

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.

Prognostic impact of global left ventricular hemodynamic afterload in severe aortic stenosis with preserved ejection fraction.

INTRODUCTION: Global left ventricular (LV) afterload as assessed by valvulo-arterial impedance (Zva), may be an independent predictor of mortality in patients with severe aortic stenosis (AS) and preserved LV ejection fraction (LVEF). However, its quantification using echocardiography may be subject to error measurement. We aimed to determine the prevalence and impact on long-term survival of high Zva, purposely measured by cardiac catheterization. METHODS AND RESULTS: 676 patients with preserved LVEF and severe AS without other valvular heart diseases underwent cardiac catheterization. Zva was derived from catheterization and calculated as follows: mean aortic gradient+systolic blood pressure/indexed LV stroke volume. Zva was considered high when >5mmHg/mL/m(2) based on previous studies. Overall, high Zva was found in 42% of all AS patients. Four-year survival and 8-year survival were significantly reduced in patients with high Zva (74±3% and 57±4%) as compared to those with low Zva (85±2% and 74±3%; p=0.002). After adjustment for all other risk factors, Zva was independently associated with reduced long-term survival (hazard ratio [HR]=1.47 95% CI: 1.04-2.09; p=0.029). Of interest, high Zva remained associated with reduced survival as compared to low Zva, in patients with normal LV stroke volume, but was no longer significant in low flow patients (p=0.98). CONCLUSION: High Zva, estimated invasively in our study, is frequent in patients with severe AS, and appears as a robust and independent predictor of survival. Zva should be used as an additional parameter for risk stratification of severe AS, more particularly in patients with normal flow.

Impact of low preprocedural transvalvular gradient on cardiovascular mortality following TAVI: an analysis from the FRANCE 2 registry.

AIMS: To assess the relationship between a low preprocedural (<40 mmHg) mean transaortic gradient (MTG) and cardiovascular mortality following transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We studied highly symptomatic patients at high surgical risk who underwent TAVI, included in the FRANCE 2 multicentre registry. The primary endpoint was the incidence of any cardiovascular death in the year following the procedure. N=3,933 patients (age=82.8±7.2 years; EuroSCORE=21.8±14.1; left ventricular ejection fraction [LVEF]=55.5±12.6%) were enrolled. Low MTG was present in 23.5% of the cases. The one-year cardiovascular mortality was 13.3%. Cardiovascular survival was significantly lower in low MTG patients compared to the others. Multivariable Cox regression analysis revealed that a low MTG independently predicted cardiovascular death (HR=1.53 [1.15-2.04], p=0.004). Other independent predictors of cardiovascular mortality included preprocedural angina (HR=3.12 [1.64-5.96], p=0.0006); NYHA functional Class III-IV (HR=1.57 [1.07-2.29], p=0.02); severe renal failure (HR=1.50 [1.01-2.24], p=0.04); EuroSCORE (HR=1.01 [1.00-1.02], p=0.01); transapical access (HR=1.59 [1.14-2.22], p=0.006); impaired LVEF (HR=1.66 [1.23-2.27], p=0.0007) and post-procedural moderate to severe periprosthetic regurgitation (HR=2.13 [1.56-2.92], p<0.0001). CONCLUSIONS: Presence of a low MTG prior to TAVI was associated with a greater risk of cardiovascular death up to one year following the procedure and could be used to identify patients at high risk for adverse cardiovascular outcomes following TAVI.

Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy.

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.