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

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.

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.

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

Registry of transcatheter aortic-valve implantation in high-risk patients.

BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

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 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.

Outcome and impact of surgery in paradoxical low-flow, low-gradient severe aortic stenosis and preserved left ventricular ejection fraction: a cardiac catheterization study.

BACKGROUND: The clinical relevance and management of paradoxical low-flow, low-gradient aortic stenosis (LFLG-AS) with preserved left ventricular ejection fraction remain debated. The aim of this study is to determine the features and outcome of LFLG-AS assessed using cardiac catheterization. METHODS AND RESULTS: Between 2000 and 2010, 768 patients with preserved left ventricular ejection fraction (>50%) and severe AS (valve area ≤ 1 cm(2)) without other valvular disease underwent cardiac catheterization. Mean age was 74 ± 8 years, 42% were women, and 46% had associated coronary artery disease. The prevalence of LFLG (indexed left ventricular stroke volume <35 mL/m(2) and mean gradient <40 mm Hg), normal flow high gradient, normal flow low gradient, and low flow high gradient were 13%, 50%, 22%, and 15%, respectively. Compared with patients with normal flow high gradient, those with LFLG were significantly older, with significantly reduced systemic arterial compliance and vascular resistances and increased valvulo-arterial impedance (all P<0.05). Ten-year survival was reduced in LFLG-AS (32 ± 9%) compared with normal flow high gradient (66 ± 4%; P=0.0002). After adjustment for other risk factors, LFLG-AS was independently associated with reduced long-term survival (hazard ratio, 1.85; 95% confidence interval, 1.08-3.07; P=0.02). However, despite higher operative mortality, patients with LFLG-AS undergoing aortic valve replacement seemed to have better long-term survival than those managed conservatively (5-year survival rate: 63 ± 6% versus 38 ± 15%; P=0.007; hazard ratio, 0.23; 95% confidence interval, 0.09-0.59; P=0.002). CONCLUSIONS: This large cardiac catheterization-based study reports that the LFLG-AS entity is not rare and is associated with worse outcome whether treated medically or surgically. However, these patients may have better long-term survival if treated surgically. Further prospective studies are needed to confirm this finding.

The prognosis of diabetic patients with high ankle-brachial index depends on the coexistence of occlusive peripheral artery disease.

OBJECTIVES: High ankle-brachial index (ABI) (>1.40) is associated with poor cardiovascular disease (CVD) prognosis. Concomittant peripheral artery disease (PAD) is frequent, although undetectable with the ABI in this situation. We assessed the prognostic value of a high ABI according to the coexistence of occlusive PAD in diabetics. METHODS: In this retrospective longitudinal study, we reviewed the data of 403 consecutive diabetic patients (hospitalized in tertiary care teaching hospital) who had a Doppler assessment of their lower limbs between 1999 and 2000. They were classified as "normal" when Doppler waveform patterns (DWP) were normal and ABI within the 0.91 to 1.39 range, "occlusive-PAD (O-PAD)" when ABI ≤0.90, or in case of abnormal DWP with normal ABI, "isolated medial calcinosis (IMC)" if ABI ≥1.40 with normal DWP, and "mixed disease (MD)" when ABI ≥1.40 with abnormal DWP. The primary outcome was the occurrence of any of the following events: death, stroke or transient ischemic attack (TIA), and acute coronary syndrome. RESULTS: The patients (65.6 ± 13.2 years, 54.6% females) were classified as normal (14.4%), O-PAD (48.4%), IMC (16.4%), and MD (20.8%). During a mean follow-up of 6.5 years, the event-free survival curves of O-PAD and MD groups showed equally poorer prognosis than the IMC and normal groups. Adjusted for age, sex, diabetes type and duration, traditional CVD risk factors, chronic kidney disease, CVD history and treatments, the presence of occlusive disease (hazard ratio [HR]: 2.21, 1.16-4.22, P = .016), but not medial calcinosis, was significantly associated with the primary outcome. CONCLUSIONS: In diabetics with ABI >1.40, only those with concommittant occlusive PAD have poorer prognosis.

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.

Heart rate and pulse pressure at rest are major prognostic markers of early postoperative complications after coronary bypass surgery.

OBJECTIVE: There is substantial evidence to consider both heart rate (HR) at rest and pulse pressure (PP) as significant markers of cardiovascular prognosis in the general population. Despite this, neither of these two parameters has been taken into consideration in the design of modern coronary artery bypass risk prediction scores, and little data on their early postoperative prognostic value are currently available. We aimed to assess the predictive value of preoperative HR and PP in the 30-day postoperative period. METHODS: We prospectively enrolled all patients referred to our institution for non-urgent coronary artery bypass grafting. We measured HR on ECG at admittance. Preoperative pulse pressure was obtained by the difference of the mean of three consecutive systolic and diastolic blood pressures. The primary outcome combined the 30-day postoperative mortality, myocardial infarction (new Q-waves on ECG or Troponin-I >20 microg/l) and stroke or transient ischemic attack. The secondary outcome corresponded to clinical events only (stroke or death). Statistical analysis was performed by usual methods. RESULTS: We enrolled 1022 patients (age 66.9+/-9.2 years). Those meeting the primary outcome (n=146) had a significantly higher HR (69.9+/-14.3 bpm vs 64.9+/-13.2 bpm, p<0.0001) and a higher proportion presented a PP >70 mmHg (17.1% vs 10.2%, p<0.03). After adjustments for age, gender, systolic blood pressure, preoperative beta-blocker therapy, left ventricular ejection fraction <0.40, unstable cardiac status, redo surgery, peripheral arterial disease, renal failure, and combined vascular surgery, both HR (OR=1.17 per 10 bpm, p<0.03) and PP >70 mmHg (OR=1.99, p=0.03) remained significant risk predictors. Similar results were found when considering only clinical events. CONCLUSION: This prospective study highlights the usefulness of HR and PP as preoperative risk markers in CABG candidates.

Subclinical peripheral arterial disease and incompressible ankle arteries are both long-term prognostic factors in patients undergoing coronary artery bypass grafting.

OBJECTIVES: This study was designed to determine the prevalence of peripheral arterial disease (PAD) in candidates for coronary artery bypass grafting (CABG) and to assess the predictive value of different types of subclinical PAD (peripheral occlusive disease and medial arterial calcification [incompressible ankle arteries]). BACKGROUND: Observational studies report poor prognosis after CABG in the presence of clinical PAD, but data on subclinical PAD are scarce. METHODS: We prospectively enrolled CABG candidates and measured ankle-brachial index (ABI) preoperatively. Patients were divided into four groups: clinical PAD, subclinical PAD (ABI <0.85), incompressible arteries (ABI >1.5), and no PAD. The primary end point was a composite combining death, acute coronary syndrome, stroke or transient ischemic attack (TIA), and coronary or peripheral revascularization. Secondary end points were overall and cardiovascular death, acute coronary syndrome, and stroke or TIA. Statistical analyses were performed using the Cox regression model. RESULTS: We consecutively enrolled 1,022 patients (mean age 66.9 +/- 9.2 years). In addition to the 14% with clinical PAD, we detected subclinical PAD in 13% and medial artery calcification in 12%. During an actuarial follow-up of 4.4 years, 81.2% of patients remained event-free. Adverse factors were (p < 0.05) supraventricular arrhythmia (odds ratio [OR] 2.5), ejection fraction <0.40 (OR 2.3), combined valvular surgery (OR 2.5), clinical PAD (OR 3.6), subclinical PAD (OR 3.3), and medial artery calcification (OR 1.9). The latter three factors were also independently predictive for overall and cardiovascular death. CONCLUSIONS: Beyond clinical PAD, the measurement of ABI before coronary surgery provides substantial information on long-term postoperative prognosis. To our knowledge, this is the first study highlighting the prognostic role of incompressible ankle arteries in secondary prevention.

Tracheal replacement with an aortic autograft.

Tracheal replacement after extensive resection remains a challenge for the thoracic surgeon. We propose an innovative solution: the use of an aortic autograft. After an experimental work on animals with aortic autografts and allografts [Martinod E, Seguin A, Pfeuty K, Fornes P, Kambouchner M, Azorin JF, Carpentier AF. Long-term evaluation of the replacement of the trachea with an autologous aortic graft. Ann Thorac Surg 2003;75(5):1572-8; Martinod E, Seguin A, Holder-Espinasse M, Kambouchner M, Duterque-Coquillaud M, Azorin JF, Carpentier AF. Tracheal regeneration following tracheal replacement with an allogenic aorta. Ann Thorac Surg 2005;79(3):942-8], we present the first human case of long tracheal replacement with an aortic autograft. In this case we replaced 7 cm of a tumoral trachea using an aortic infra-renal autograft supported by a silicone stent. The early postoperative course was uneventful. The stent was removed at three months. The patient died at six months from an acute pulmonary infection without any sign of anastomosis leakage or graft rupture. A new field of clinical study has to be investigated.

Predictive factors of stroke in patients undergoing coronary bypass grafting: statins are protective.

BACKGROUND: Despite major improvement in surgical techniques and intensive care management, stroke remains one of the most devastating complications of coronary artery bypass grafting (CABG). We aimed to determine factors predicting the occurrence of stroke during CABG. A special interest was focused on preoperative therapies. METHODS: We prospectively enrolled 810 consecutive candidates for CABG alone in a specific database, including all pre- and perioperative data (history, clinical, therapeutic, cardiac catheterization, surgical and intensive care data). Univariate tests and then multiple logistic regression analysis were used to determine independent predictive factors. RESULTS: During the first postoperative month, stroke occurred in 11 cases and transient ischemic attack (TIA) in 4 additive cases (cumulative rate: 1.85%). After the multivariate analysis, the following factors remained significant (p<0.05) in the predictive model, with corresponding odds ratios between brackets: redo cardiac surgery (7.45), unstable cardiac status (4.74), past history of cerebrovascular disease (4.14), past history of peripheral arterial disease (3.55), whereas the presence of preoperative statins was protective (0.24, 95% IC: 0.07-0.78). The addition of perioperative data (aortic calcification, postoperative arrhythmia, on/off-pump surgery) did not change the final predictive model. CONCLUSION: To our knowledge, this is the first real-world observational report highlighting the interest of statins for the prevention of stroke in the very special situation of CABG. Even though according to randomized trials coronary patients have a benefit from these drugs, a special level of interest should be directed towards those presenting the above-mentioned risk factors.

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.

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.

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.

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.

Common carotid intima-media thickness measurement is not a pertinent predictor for secondary cardiovascular events after coronary bypass surgery. A prospective study.

OBJECTIVE: We aimed to assess the utility of common carotid intima-media thickness (CCA-IMT) to predict secondary cardiovascular events after coronary artery bypass grafting (CABG). In primary prevention, carotid-IMT is known as a valuable cardiovascular risk marker, but its interest in secondary prevention has been less studied. We hypothesized that CCA-IMT could be used for peri-operative and long-term risk stratification in candidates for CABG. METHODS: A total of 609 patients (66.8+/-9.2 years) were prospectively enrolled for preoperative CCA-IMT measurement and follow-up. The primary end-point combined cardiovascular death, non-fatal acute coronary syndromes, stroke, secondary coronary revascularization and peripheral arterial surgery during follow-up. The secondary end-point was the 1-month post-operative death. Univariate and multivariate analysis were performed by usual methods. RESULTS: A subgroup of 150 patients (24.6%) was individualized with a CCA-IMT above 90th percentile (>0.90 mm) or presenting plaques in their CCA. At 1 month, there was no significant difference in the prevalence of elevated CCA-IMT between deceased patients and survivors (16.7 vs. 24.9%, P=ns). During a mean follow-up of 41.8+/-16 months, 121 patients (19.8%) met the primary end-point. High CCA-IMT was predictive (OR=1.67, 95% CI 1.14-2.46, P=0.009) in the univariate analysis. In the multivariate analysis, age (OR=1.03, 95% CI 1.00-1.05, P=0.029) concomitant valvular surgery (OR=2.17, P=0.003) arrhythmia (OR=2.20, P=0.021), and peripheral arterial disease (OR=2.41, P<0.001) were significant independent prognostic factors whereas CCA-IMT failed to remain independently significant. CONCLUSIONS: Pre-operative CCA-IMT can provide prognostic information for candidates to CABG. However, clinical data present stronger prognostic values.

[Management of acute leg ischemia]. / Prise en charge d'un patient ayant une oblitération artérielle aiguë des membres inférieurs.

Nowadays acute limb ischemia (ALI) is still a tremendous complication that may compromise local or general prognosis. Every practician might be able to diagnose this situation in order to transfer in emergency the patient in a vascular unit. The main determinants of outcome of the leg are the severity of the ALI and a prompt treatment. The severity is evaluated according the SCV/ISCVS classification. Patients with a sensitive-motor neurologic deficit are at high risk; they require urgent therapy. The main causes are embolism and thrombosis. In case of classical presentation of embolism, immediate embolectomy will be done under local anesthetic. But this presentation is rare; often the picture is much more complex; the majority of ALI patients are elderly with atherosclerotic vessels. In such situation a team approach is mandatory to decide optimal management. The treatment may combine thrombolytic therapy or aspiration thrombectomy and percutaneous or surgical revascularisation. Finally, atrial fibrillation is now the most common cause of embolism, and appropriate anticoagulation would prevent this complication.