Publications by authors named "Marc Laskar"

59 Publications

Femoral Versus Nonfemoral Peripheral Access for Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2019 12;74(22):2728-2739

Department of Cardiology, La Cavale Blanche University Hospital Centre, Optimization of Physiological Regulations, Science and Technical Training And Research Unit, University of Western Brittany, Brest, France.

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.
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http://dx.doi.org/10.1016/j.jacc.2019.09.054DOI Listing
December 2019

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

J Am Coll Cardiol 2016 10;68(15):1637-1647

Department of Cardiology, Brest University Hospital, Brest, France.

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.
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http://dx.doi.org/10.1016/j.jacc.2016.07.747DOI Listing
October 2016

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

Int J Cardiol 2016 May 13;210:72-9. Epub 2016 Feb 13.

Cardiology Department, Hôpital Henri-Mondor, Assistance-Publique-Hôpitaux-de-Paris, 51 Avenue du Maréchal de Lattre de Tassigny, 94000 Creteil, France.

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.
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http://dx.doi.org/10.1016/j.ijcard.2016.02.073DOI Listing
May 2016

Fate of aortic bioprostheses: An 18-year experience.

J Thorac Cardiovasc Surg 2016 Mar 23;151(3):754-761.e1. Epub 2015 Oct 23.

Department of Thoracic and Cardiovascular Surgery, "Dupuytren" University Hospital, Limoges, France.

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.
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http://dx.doi.org/10.1016/j.jtcvs.2015.10.020DOI Listing
March 2016

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

Eur J Cardiothorac Surg 2016 Mar 29;49(3):709-18. Epub 2015 Oct 29.

King Fahad National Guard Hospital, Riyadh, Saudi Arabia.

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.
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http://dx.doi.org/10.1093/ejcts/ezv369DOI Listing
March 2016

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

JACC Cardiovasc Interv 2015 Aug;8(10):1346-1355

Department of Cardiology, EA3920, University Hospital Besançon, Besançon, France.

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.
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http://dx.doi.org/10.1016/j.jcin.2015.06.010DOI Listing
August 2015

[From FRANCE 2 to FRANCE TAVI: are indications, technique and results of transcatheter aortic valve replacement the same?].

Presse Med 2015 Jul-Aug;44(7-8):752-60. Epub 2015 Jul 22.

CHU de Rennes, service de cardiologie et des maladies vasculaires, 35000 Rennes, France; Université Rennes 1, LTSI, 35000 Rennes, France; Inserm U1099, 35000 Rennes, France.

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.
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http://dx.doi.org/10.1016/j.lpm.2015.05.004DOI Listing
January 2016

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

Am J Cardiol 2015 Aug 9;116(3):420-5. Epub 2015 May 9.

Department of Cardiology, Brest University, Brest, France. Electronic address:

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.
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http://dx.doi.org/10.1016/j.amjcard.2015.04.057DOI Listing
August 2015

Coronary Artery Embolism Following Aortic Valve Replacement.

J Card Surg 2015 Jul 7;30(7):581-2. Epub 2015 May 7.

Department of Thoracic and Cardiovascular Surgery and Angiology, Dupuytren University Hospital Center, Limoges, France.

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http://dx.doi.org/10.1111/jocs.12567DOI Listing
July 2015

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

Am J Cardiol 2015 May 12;115(9):1273-80. Epub 2015 Feb 12.

Cardiology Department, University Hospital Clermont, Ferrand, France.

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.
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http://dx.doi.org/10.1016/j.amjcard.2015.01.560DOI Listing
May 2015

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

Heart 2015 May 9;101(10):781-7. Epub 2015 Mar 9.

CHU Limoges, Hôpital Dupuytren, Service Cardiologie, Limoges, France INSERM 1094, Faculté de médecine de Limoges, Limoges, France.

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.
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http://dx.doi.org/10.1136/heartjnl-2014-306953DOI Listing
May 2015

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

Int J Cardiol 2015 Mar 30;183:98-104. Epub 2015 Jan 30.

CardiologyDepartment HôpitalHenri-Mondor, Assistance-Publique-HôpitauxdeParis & INSERM-U955, 51 Avenue du Maréchal de Lattre de Tassigny, 94000 Creteil, France.

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.
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http://dx.doi.org/10.1016/j.ijcard.2015.01.037DOI Listing
March 2015

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).

Catheter Cardiovasc Interv 2015 Jun 3;85(7):1231-9. Epub 2015 Feb 3.

Department of Cardiology, CHU Brest, Brest, France.

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.
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http://dx.doi.org/10.1002/ccd.25832DOI Listing
June 2015

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

EuroIntervention 2015 Jan;10(9):e1-9

Centre Hospitalier Universitaire (CHU) Henri Mondor, Créteil, France.

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.
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http://dx.doi.org/10.4244/EIJV10I9A183DOI Listing
January 2015

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

Catheter Cardiovasc Interv 2015 Sep 18;86(3):E158-66. Epub 2015 Feb 18.

Cardiology Department, Hôpital Henri Mondor, Assistance Publique Hôpitaux De Paris & INSERM U 955, Creteil, France.

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.
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http://dx.doi.org/10.1002/ccd.25818DOI Listing
September 2015

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

Int J Cardiol 2015 Feb 26;180:158-64. Epub 2014 Nov 26.

CHU Limoges, Hôpital Dupuytren, Service Cardiologie, Limoges, F-87042, France; INSERM 1094, Faculté de médecine de Limoges, 2, rue Marcland, 87000 Limoges, France; CHU Limoges, Hôpital Dupuytren, Service de Chirurgie Thoracique et Cardiovasculaire, Limoges F-87042, France.

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.
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http://dx.doi.org/10.1016/j.ijcard.2014.11.180DOI Listing
February 2015

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

EuroIntervention 2014 Nov;10(7):842-9

Institut Mutualiste Montsouris, Paris, France.

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.
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http://dx.doi.org/10.4244/EIJV10I7A144DOI Listing
November 2014

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

JACC Cardiovasc Interv 2014 Oct 17;7(10):1138-45. Epub 2014 Sep 17.

Clinique Pasteur, Toulouse, France.

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.
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http://dx.doi.org/10.1016/j.jcin.2014.04.018DOI Listing
October 2014

Prevalence and long-term outcome of aortic prosthesis-patient mismatch in patients with paradoxical low-flow severe aortic stenosis.

Circulation 2014 Sep;130(11 Suppl 1):S25-31

From the CHU Limoges, Hôpital Dupuytren, Service Cardiologie (D.M., C.B., J.M., N.E., P.V., V.A.) and Service de Chirurgie thoracique et cardiovasculaire (E.C., M.L.), Limoges, France; INSERM 1094, Faculté de médecine de Limoges, Limoges, France (D.M., J.M.); and Québec Heart & Lung Institute, Department of Medicine, Laval University, Quebec City, Quebec, Canada (P.P., J.D.).

Background: Patients with severe aortic stenosis (AS) and paradoxical low flow (PLF) have worse outcome compared with those with normal flow. Furthermore, prosthesis-patient mismatch (PPM) after aortic valve replacement is a predictor of reduced survival. However, the prevalence and prognostic impact of PPM in patients with PLF-AS are unknown. We aimed to analyze the prevalence and long-term survival of PPM in patients with PLF-AS.

Methods And Results: Between 2000 and 2010, 677 patients with severe AS, preserved left ventricular ejection fraction, and aortic valve replacement were included (74±8 years; 42% women; aortic valve area, 0.69±0.16 cm(2)). A PLF (indexed stroke volume ≤35 mL/m(2)) was found in 26%, and after aortic valve replacement, 54% of patients had PPM, defined as an indexed effective orifice area ≤0.85 cm(2)/m(2). The combined presence of PLF and PPM was found in 15%. Compared with patients with noPLF/noPPM, those with PLF/PPM were significantly older, with more comorbidities. They also received smaller and biological bioprosthesis more often (all P<0.01). Although early mortality was not significantly different between groups, the 10-year survival rate was significantly reduced in case of PLF/PPM compared with noPLF/noPPM (38±9% versus 70±5%; P=0.002), even after multivariable adjustment (hazard ratio, 2.58; 95% confidence interval, 1.5-4.45; P=0.0007).

Conclusions: In this large catheterization-based study, the coexistence of PLF-AS before surgery and PPM after surgery is associated with the poorest outcome.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.113.007819DOI Listing
September 2014

Prevalence of renal artery disease and its prognostic significance in patients undergoing coronary bypass grafting.

Am J Cardiol 2014 Oct 24;114(7):1029-34. Epub 2014 Jul 24.

Inserm U1094, School of Medicine, University of Limoges, Limoges, France; Department of Thoracic & Cardiovascular Surgery and Angiology, Dupuytren University Hospital, Limoges, France.

Several studies demonstrated the prognostic importance of renal failure and peripheral artery disease in patients undergoing coronary artery bypass grafting (CABG), but data regarding the prognostic value of renal artery disease in this context are scarce. We aimed to study the prevalence and prognostic value of renal artery disease in patients undergoing CABG. We assessed by duplex ultrasound the renal arteries of 429 consecutive patients who underwent CABG, of whom 401 had satisfactory imaging quality to detect >60% renal artery stenosis (RAS) and/or an elevated resistive index (ERI>0.80). Of the 401 subjects included (age 68±10 years, 83% men), 40 (10%) had RAS and 35 (9%) had ERI. Nine patients (2.2%) had both conditions. Patients were followed up for 12.4±7.0 months. The primary outcome was composite, including 30-day death, stroke, and/or myocardial infarction. In a multivariate model adjusted for age, gender, cardiovascular (CV) risk factors, renal function, chronic obstructive pulmonary disease, the use of off-pump CABG, CV co-morbidities, and drugs, the presence of ERI was strongly associated with the occurrence of the composite outcome (odds ratio 4.3, 95% confidence interval 1.7 to 9.9, p=0.0006). Similarly, ERI, not RAS, was significantly associated with the 30-day acute kidney disease and the midterm mortality, as well as fatal and nonfatal CV events. In conclusion, regardless of renal function and other factors, the renal resistive index is a strong predictor of CV and renal events after CABG. Renal duplex ultrasound can identify a subgroup of patients at high risk of CABG.
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http://dx.doi.org/10.1016/j.amjcard.2014.07.011DOI Listing
October 2014

Clinical outcomes and safety of transfemoral aortic valve implantation under general versus local anesthesia: subanalysis of the French Aortic National CoreValve and Edwards 2 registry.

Circ Cardiovasc Interv 2014 Aug 8;7(4):602-10. Epub 2014 Jul 8.

From the Centre Hospitalier Universitaire (CHU) Henri Mondor, Creteil, France (A.O., M.Y., G.M., K.C., J.-L.D.-R., E.T.); Centre Hospitalier Universitaire Brest, Brest, France (M.G.); Centre Hospitalier Universitaire Dupuytren, Limoges, France (M. Laskar); Hopital Charles Nicolle, University of Rouen, INSERM Unite 1096, Rouen, France (H.E.); Clinique Pasteur, Toulouse, France (J.F.); Bichat Hospital, Paris, France (B.I.); Insitut Jacques Cartier, Massy, France (P.D.-G.); Pitie-Salpetriere Hospital, Paris, France (P.L.); Centre Hospitalier Universitaire Rennes, Rennes, France (A.L.); Centre Hospitalier Universitaire Lille, Lille, France (A.P., E.V.B.); University Lyon 1, Lyon, France (M. Lievre); Centre Hospitalier Universitaire Besançon, Besançon, France (R.C.); and Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan (T.O.).

Background: Transcatheter aortic valve implantation (TAVI) performed under local anesthesia (LA) is becoming increasingly common. We aimed to compare the clinical outcomes in patients who underwent transfemoral-TAVI under general anesthesia (GA) and LA.

Methods And Results: Data from 2326 patients in the French Aortic National CoreValve and Edwards 2 (FRANCE 2) registry who underwent transfemoral-TAVI were analyzed. During the study period, the percentage of LA procedures increased gradually from 14% in January 2010 to 59% in October 2011. The clinical outcomes for GA (n=1377) and LA (n=949) were compared. Numerous baseline characteristics differed between the 2 groups, and the use of transesophageal echocardiographic guidance was more common in GA than in LA (76.3% versus 16.9%; P<0.001). Device success and cumulative 30-day survival rates were similar in the 2 groups (97.6% versus 97.0%; P=0.41 and 91.6% versus 91.3%; P=0.69, respectively), whereas the incidence of postprocedural aortic regurgitation≥mild was significantly lower in GA than in LA (15.0% versus 19.1%; P=0.015). The groups were also analyzed using a propensity-matching model, including transesophageal echocardiographic usage (GA [n=401] versus LA [n=401]). This model indicated that there were no significant differences between the 2 groups in the rates of 30-day survival (GA [91.4%] versus LA [89.3%]; P=0.27] and postprocedural aortic regurgitation≥mild (GA [12.7%] versus LA [16.2%]; P=0.19).

Conclusions: The less invasive transfemoral-TAVI under LA is preferred in clinical settings and seems to be acceptable; however, the higher incidence of postprocedural aortic regurgitation is emphasized. Therapeutic efforts should be made to reduce such complications during transfemoral-TAVI under LA.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.113.000403DOI Listing
August 2014

Uterus retrieval process from brain dead donors.

Fertil Steril 2014 Aug 13;102(2):476-82. Epub 2014 May 13.

Department of Obstetrics and Gynecology, Limoges University Hospital, Limoges, France.

Objective: To describe the feasibility of human uterus retrieval after donation after brain death.

Design: Single-center, prospective study.

Setting: University hospital.

Patient(s): Female brain dead donors.

Intervention(s): The families of female brain dead donors were informed about consent to uterus donation. A specific organ retrieval procedure was performed. At the end of the procedure the uterus was removed together with the hypogastric vessels, parametria, and vaginal fornix. The tolerance of the uterus to cold ischemia was evaluated with histology and TUNEL reaction up to 24 hours.

Main Outcome Measure(s): Rate of uterus donation refusal.

Result(s): Between August 1, 2012 and July 31, 2013, seven uteri were retrieved from 14 female multiorgan donors. No refusal to uterus donation occurred. Our surgical protocol did not interfere with vital organ retrieval and was readily accepted by the other transplantation teams. The hypogastric vessels could be preserved in all cases but for one vein loss in the first retrieval. Histology studies did not find major morphologic changes after 24 hours of cold ischemia. Apoptosis was rare.

Conclusion(s): Uterus retrieval could be part of a reproducible multiorgan procurement procedure. Uterus donation seems readily accepted. This preliminary study is a necessary step before any transplantation project.
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http://dx.doi.org/10.1016/j.fertnstert.2014.04.016DOI Listing
August 2014

Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.

Heart 2014 Jul 16;100(13):1016-23. Epub 2014 Apr 16.

Cardiology Department, Hôpital de la Cavale Blanche, CHU, Brest, France.

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/m(2), 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.
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http://dx.doi.org/10.1136/heartjnl-2013-305314DOI Listing
July 2014

Impact of chronic obstructive pulmonary disease on Valve Academic Research Consortium-defined outcomes after transcatheter aortic valve implantation (from the FRANCE 2 Registry).

Am J Cardiol 2014 May 12;113(9):1543-9. Epub 2014 Feb 12.

Department of Cardiology, EA3920, University Hospital Besançon, Besançon, France.

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.
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http://dx.doi.org/10.1016/j.amjcard.2014.01.432DOI Listing
May 2014

Prognostic implications of pulmonary hypertension in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: study from the FRANCE 2 Registry.

Circ Cardiovasc Interv 2014 Apr 25;7(2):240-7. Epub 2014 Feb 25.

From the Service de Cardiologie (A.L., M.B., D.B., H.L.B.), Service de Pharmacologie Clinique (E.O.), and Service de Chirurgie Thoracique et Cardiovasculaire (J.P.V., A.L.), CHU Rennes, Rennes, France; Département de Pharmacologie, Clinique et Expérimentale, Faculté de Médecine (E.O.) and LTSI (J.P.V., H.L.B.), Université de Rennes 1, Rennes, France; INSERM 0203, Centres d'Investigation Clinique, Rennes, France (E.O.); INSERM, U642, Rennes, France (J.P.V., H.L.B.); CHU Rouen, Hôpital Charles Nicolle, INSERM Unité 1096, Rouen, France (H.E.); CHU Bichat, Paris, France (B.I.); CHU Dupuytren, Limoges, France (M.L.); CHU Pitié-Salpêtrière, Paris, France (P.L.); and CHU Brest, Brest, France (M.G.).

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.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.113.000482DOI Listing
April 2014

Postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures: analysis of predictors and impact on long-term mortality: insights from the FRANCE2 Registry.

Circulation 2014 Apr 24;129(13):1415-27. Epub 2014 Feb 24.

Department of Cardiology, University Hospital, Lille, France (E.V.B., F.J., A.V., C.B., J.-L.A., C.D., A.P.); EA2693, Lille-II-University, Lille, France (E.V.B., F.J., S.S., A.V., C.B., J.-L.A., C.D., A.P.); INSERM-U744, Lille, France (J.D.); CHU Bichat, Paris, France (B.I.); CHU Rouen, Rouen, France (H.E.); CHU Dupuytren, Limoges, France (M. Laskar); CHU Pitié-Salpêtrière, Paris, France (P.L.); University Lyon-1, Lyon, France (M. Lievre; Institut cardiovasculaire Paris-Sud, Paris, France (P.D.-G.); URC-ECO, Paris, France (K.C.); Clinique Pasteur, Toulouse, France (J.F.); CHU Rennes, Rennes, France (A.L.); CHU Brest, Brest, France (M.G.); and CHU Mondor Créteil, Créteil, France (E.T.).

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
Conclusions: Postprocedural AR≥grade 2 was observed in 15.8% of successful TAVR and was the strongest independent predictor of 1-year mortality. The use of the SE device was a powerful independent predictor of postprocedural AR≥grade 2.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.113.002677DOI Listing
April 2014

Comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation.

Am J Cardiol 2014 Jan 5;113(2):355-60. Epub 2013 Oct 5.

University Hospital of Rouen, Hospital Charles Nicolle, Departments of Cardiology and Thoracic and Cardiovascular Surgery, INSERM UMR 1096, Rouen, France.

Dual antiplatelet therapy is commonly used in patients undergoing transcatheter aortic valve implantation (TAVI), but the optimal antiplatelet regimen is uncertain and remains to be determined. The objective of this study was to compare 2 strategies of antiplatelet therapy in patients undergoing TAVI. A strategy using monoantiplatelet therapy (group A, n = 164) was prospectively compared with a strategy using dual antiplatelet therapy (group B, n = 128) in 292 consecutive patients undergoing TAVI. The primary end point was a combination of mortality, major stroke, life-threatening bleeding (LTB), myocardial infarction, and major vascular complications at 30 days. All adverse events were adjudicated according to the Valve Academic Research Consortium. The primary end point occurred in 22 patients (13.4%) in the group A and in 30 patients (23.4%) in the group B (hazard ratio 0.51, 95% confidence interval 0.28 to 0.94, p = 0.026). LTB (3.7% vs 12.5%, p = 0.005) and major bleedings (2.4% vs 13.3%, p <0.0001) occurred less frequently in the group A, whereas the incidence of stroke (1.2% vs 4.7%, p = 0.14) and myocardial infarction (1.2% vs 0.8%, p = 1.0) was not significantly different between the 2 groups. The benefit of a strategy using mono versus dual antiplatelet therapy persisted after multivariate adjustment and propensity score analysis (hazard ratio 0.53, 95% confidence interval 0.28 to 0.95, p = 0.033). In conclusion, a strategy using mono versus dual antiplatelet therapy in patients undergoing TAVI reduces LTB and major bleedings without increasing the risk of stroke and myocardial infarction. The results of our study question the justification of dual antiplatelet therapy and require confirmation in a randomized trial.
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http://dx.doi.org/10.1016/j.amjcard.2013.09.033DOI Listing
January 2014

Clinical results of transcatheter aortic valve implantation in octogenarians and nonagenarians: insights from the FRANCE-2 registry.

Ann Thorac Surg 2014 Jan 17;97(1):29-36. Epub 2013 Oct 17.

Centre Hospitalier Universitaire (CHU)-Henri Mondor, Creteil, France.

Background: Although transcatheter aortic valve implantation has been developing as an alternative treatment in elderly patients with high surgical risk, age-specific differences in clinical outcome have not been fully validated.

Methods: Data were analyzed for 2,254 patients at least 80 years old who were enrolled between January 2010 and October 2011 in the French national transcatheter aortic valve implantation registry, FRANCE-2. Procedural and clinical outcomes defined according to the Valve Academic Research Consortium criteria were compared among subjects in three age groups: 80 to 84 years (n = 867), 85 to 89 years (n = 1,064), and at least 90 years (n = 349; range, 90 to 101 years).

Results: The self-expandable prosthesis was implanted in 710 patients, and the balloon-expandable prosthesis was implanted in 1,544 patients. No differences were observed in rates of procedural success, Valve Academic Research Consortium-defined complications, and length of hospitalization among groups. Cumulative 30-day mortalities did not change among the three groups (80 to 84 years, 10.3% versus 85 to 89 years, 9.5% versus ≥ 90 years, 11.2%; p = 0.53). Cumulative 1-year mortalities also showed no statistical differences, although the mortality rate was higher in patients 85 to 89 years old and at least 90 years old compared with those 80 to 84 years old (19.8% versus 26.1% versus 27.7%; p = 0.16). After adjustment for differential baseline characteristics and potential confounders, patient age (85 to 89 years and ≥ 90 years compared with 80 to 84 years) was not associated with increasing risk of 30-day mortality (hazard ratio, 0.92, 1.26; 95% confidence interval, 0.66 to 1.27, 0.83 to 1.94; p = 0.38, 0.28, respectively) and 1-year mortality (hazard ratio, 1.16, 1.36; 95% confidence interval, 0.90 to 1.49, 0.97 to 1.89; p = 0.25, 0.073, respectively).

Conclusions: This study revealed acceptable clinical results of transcatheter aortic valve implantation even in very elderly populations.
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http://dx.doi.org/10.1016/j.athoracsur.2013.07.100DOI Listing
January 2014