Alain Leguerrier

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.).

Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry

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

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<grade 2 at baseline (31%), low transaortic gradient (35%), or nonfemoral delivery (45%). 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.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<grade 2 at baseline (31%), low transaortic gradient (35%), or nonfemoral delivery (45%). 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. # CLINICAL PERSPECTIVE {#article-title-26}

Valve replacement in patients with critical aortic stenosis and depressed left ventricular function: predictors of operative risk, left ventricular function recovery, and long term outcome

Objectives: To identify predictors of operative and postoperative mortality and of functional reversibility after aortic valve replacement (AVR) in patients with aortic stenosis (AS) and severe left ventricular (LV) systolic dysfunction. Methods and results: Between 1990 and 2000, 155 consecutive patients (mean (SD) age 72 (9) years) in New York Heart Association (NYHA) heart failure functional class III or IV (n  =  138) and with LV ejection fraction (LVEF) ⩽ 30% underwent AVR for critical AS (mean (SD) valve area index 0.35 (0.09) cm2/m2). Thirty day mortality was 12%. NYHA class (3.7 (0.6) v 3.2 (0.7), p  =  0.004), cardiothoracic ratio (CTR) (0.63 (0.07) v 0.56 (0.06), p < 0.0001), pulmonary artery systolic pressure (63 (25) v 50 (19) mm Hg, p  =  0.03), and prevalence of complete left bundle branch block (22% v 8%, p  =  0.03) and of renal insufficiency (p  =  0.001) were significantly higher in 18 non-survivors than in 137 survivors. In multivariate analysis, the only independent predictor of operative mortality was a CTR ⩾ 0.6 (odds ratio (OR) 12.2, 95% confidence interval (CI) 5.4 to 27.4, p  =  0.002). The difference between preoperative and immediate postoperative LVEF (early-ΔEF) was > 10 ejection fraction units (EFU) in 55 survivors. In multivariate analysis, CTR (OR 5.95, 95% CI 3.0 to 11.6, p  =  0.006) and mean transaortic gradient (OR 1.05, 95% CI 1.0 to 1.1, p < 0.05) were independent predictors of an early-ΔEF > 10 EFU. During a mean (SD) follow up of 4.6 (3) years, 50 of 137 (36%) 30 day survivors died, 31 of non-cardiac causes. Diabetes (OR 3.8, 95% CI 2.4 to 6.0, p  =  0.003), age ⩾ 75 years (OR 2.6, 95% CI 2.1 to 4.5, p  =  0.004), and early-ΔEF ⩽ 10 EFU (OR 0.96, 95% CI 0.94 to 0.97, p  =  0.01) were independent predictors of long term mortality. Among 127 survivors, the percentage of patients in NYHA functional class III or IV decreased from 89% preoperatively to 3% at one year. The decrease in functional class was significantly greater in patients with an early-ΔEF > 10 EFU than patients with an early-ΔEF ⩽ 10 EFU (p  =  0.02). In addition, the mean (SD) LVEF at one year was 53 (11)% in patients with an early-ΔEF > 10 EFU and 42 (11)% in patients with early-ΔEF ⩽ 10 EFU (p < 0.001). Conclusions: Despite a relatively high operative mortality, AVR for AS and severely depressed LVEF was beneficial in the majority of patients. Early postoperative recovery of LV function was associated with significantly greater relief of symptoms and longer survival.

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

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

Surgery for aortic stenosis in elderly patients. A study of surgical risk and predictive factors.

BackgroundAortic stenosis is the most common valvular lesion occurring among elderly patients and has become extremely frequent because of changing demographics in industrialized countries. Surgical risk after the age of 70 has increased. The increasing older age of patients having surgery justifies an analysis of mortality predictive factors. Methods and ResultsBetween 1976 and February 1993, we performed 2871 operations for aortic stenosis. This study concerns 675 patients (278 men and 397 women) who were ≥ 75 years old. Mean age was 78.5 ± 3 years. Associated lesions were found in 226 patients. A bioprosthesis was implanted in 632 patients (93.6%). Concomitant surgical procedures were performed in 133 patients. Surgical mortality was 12.4% (84 deaths). A longitudinal analysis has been carried out over four successive time periods to evaluate population evolution during these 17 years. Statistical analysis was performed on 46 variables. Multivariate analysis found age (P < .0001), left ventricular failure (P < .0001), lack of sinus rhythm (P < .01), and emergency status (P < .02) to be presurgical independent predictive factors of mortality. ConclusionsRisk-reducing strategy should both favor relatively early surgery to avoid cardiac failure and emergency situations and pay careful attention to the use of myocardial protection and cardiopulmonary bypass. Indications for surgery should remain broad since analysis failed to determine specific high-risk groups to be eliminated, and surgery remains the only treatment for aortic stenosis.

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

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.

Prognostic Implications of Pulmonary Hypertension in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation Study From the FRANCE 2 Registry

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.

Isolated left main coronary artery stenosis: long term follow up in 106 patients after surgery

Objective: To analyse the long term prognosis in patients with isolated stenoses of the left main coronary artery (LMCA) following surgical revascularisation. Patients: 106 patients (71 men and 35 women, mean age 61 years) were operated on between 1982 and 1998. Before surgery, 103 patients presented with angina pectoris and only 10 had a history of myocardial infarction. Their mean left ventricular ejection fraction was 62%. Stenoses were localised on the LMCA ostium in 19 patients, a subgroup characterised by a high proportion of women (68%). Three patients presented with chronic LMCA occlusion. Forty six patients were operated on as an emergency. The mean (SD) number of grafts per patient was 2.0 (0.5), and only one patient had no left anterior descending (LAD) coronary artery bypass. Bypass of the LAD using the internal thoracic artery was performed in 88 cases. Results: Early postoperative mortality was 4.7% and the five year survival was 86.8%. Late mortality occurred in nine cases, and in three of these it was linked to a coronary condition. Of the 92 long term survivors, 81.5% were totally symptom-free and 77% of those of working age were able to resume work. The postoperative outcome of patients with isolated ostial LMCA stenosis did not differ significantly from that of the other patients. Conclusions: The postoperative prognosis of isolated LMCA stenosis appears good in terms of mortality and symptoms.

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

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