Methods

FRANCE 2 is a consecutive, multicenter, prospective registry involving 33 centers in France and 1 in Monaco. Details have previously been reported. Briefly, patients included in the registry were symptomatic adults with severe aortic stenosis who were not AVR candidates because of co-morbidity. Severe aortic stenosis was defined by aortic valve area <0.8 cm ² , mean aortic valve gradient ≥40 mm Hg, or peak aortic jet velocity ≥4.0 m/s. Risk factors for cardiovascular surgery were assessed on the Society of Thoracic Surgeons (STS) score (STS score >10% indicating very high surgical risk) and the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), which is calculated by a logistic regression equation (EuroSCORE >20% indicating very high surgical risk).

All patients had New York Heart Association (NYHA) class II, III, or IV symptoms. All patients who underwent TAVI in France and Monaco since January 2010 on the basis of these criteria were prospectively included in the registry, without exclusion criteria. Patients provided written informed consent before they underwent the procedure, including consent for anonymous processing of their data.

TAVI was performed in 3,761 patients in 34 hospitals from January 2010 to December 2011. Data were divided into 2 groups on the basis of previous CABG for analysis of baseline.

The technical aspects of the TAVI procedure have been previously reported in detail. Both of the commercially available valves were used: the balloon-expandable prosthesis known as the Edwards SAPIEN valve (first and second generation; Edwards Lifesciences, Irvine, California) and the self-expandable prosthesis known as the Medtronic CoreValve Revalving System (Medtronic, Minneapolis, Minnesota). Each team was free to choose the model to be used. All adopted a “transfemoral (TF) approach first” policy. Criteria for resort to other approaches were based on size and degree of tortuosity, calcification, and aorto-iliofemoral arterial tree atheroma; the other approaches were transapical (TA), subclavian, or direct transaortic or carotid route. All subjects received aspirin (≥160 mg daily) and clopidogrel (300 mg loading dose, then 75 mg daily) before vascular access and aspirin alone for at least 1 month thereafter.

The primary end point of this analysis was death from any cause at 1 month, 6 months, and 1 year. Secondary safety end points were major adverse events on Valve Academic Research Consortium (VARC) criteria.

An independent clinical events committee adjudicated mortality and other adverse events. All adverse events were assessed on the VARC classification. Postprocedural aortic and mitral regurgitation were assessed by echocardiography, with periodic assessment of aortic valve function during the first 3 years, including mean gradient and valve area, and presence and severity of aortic valve or mitral valve regurgitation. Regurgitation severity was graded on a scale from 0 to 4, with higher grades indicating greater severity.

Symptomatic status on the NYHA classification was assessed at 30 days, 6 months, and 1 year. Data were recorded on a standardized electronic case report form and sent to a central database (AXONAL, Nanterre, France) through the Internet.

Database quality control was performed by checking data against source documents for 10% of patients in randomly selected centers. All fields were examined for missing data or outliers, and teams were asked to complete or correct data wherever possible. Outlying data were checked and excluded if erroneous; such exclusion concerned <1% of the data.

Absolute numbers, percentages, and means (±SD) were computed to describe the population. Mortality was calculated on the Kaplan-Meier survival analysis. Comparison between groups and univariate analysis of associated variables used Student’s t test, analysis of variance or nonparametric tests for continuous variables, and a chi-square or Fisher’s exact test for categorical variables. A univariate Cox model was used to analyze 1-year survival data, with a p value <0.10 indicating statistical significance. A multivariate Cox model with stepwise regression, adjusted for age, approach, logistic EuroSCORE, NYHA class, presence or absence of history of cerebral vascular disease or myocardial infarction, number of patients included per study center, and presence or absence of periprosthetic regurgitation, was used to assess hazard ratios (HRs). All tests were 2 sided. A p value of 0.05 indicated statistical significance. All analyses were performed on SAS software, version 8.2.

Results

Six hundred and eighty-three of the 3,761 patients in the FRANCE 2 Registry (18%) had history of CABG. There were numerous baseline differences between groups ( Table 1 ). Patients with previous CABG were more often men, significantly younger, and had higher rates of diabetes, previous myocardial infarction, aortic abdominal aneurysm, and peripheral vascular disease and lower rates of chronic obstructive pulmonary disease and renal dialysis, left ventricle ejection fraction, and pulmonary hypertension. Consequently, mean logistic EuroSCORE was higher in the group with previous CABG (29.8 ± 16.4 vs 20.1 ± 13.0, p <0.001), as was mean preoperative surgical risk, whereas functional class and aortic valve area reduction on echocardiography were less severe.

Procedural characteristics and outcomes are listed in Table 2 . Edwards SAPIEN devices were implanted in 66.8% of patients, and Medtronic CoreValve devices in the others, without difference between groups. The rate of general anesthesia was significantly higher in the previous CABG group. Implantation approach was TF in 75.6% of all patients, TA in 17.8%, subclavian in 5.8%, and transaortic or transcarotid in 1.8%. TF was significantly less frequent with previous CABG (420 [62.5%] vs 2,327 [78.6%], p <0.001) and TA significantly more frequent (207 [30.8%] vs 466 [15.7%]). Procedural success rates were high in both groups. There were no significant differences in VARC complications (myocardial infarction, stroke or vascular, and bleeding complications) or other procedural complications.

At 30 days, mortality rate from all causes on Kaplan-Meier analysis (primary end point) was 9.2% in the cohort as a whole ( Table 3 ) and 16.1% at 6 months (110 patients) and 19.0% at 1 year (130 patients). The rate of cardiovascular mortality was 12.3% at 1 year. Mortality rates were similar in the 2 groups ( Figure 1 ).

Table 3

Functional class and mortality

	All patients (n=3,761)	Previous CABG		p
		Yes ( n=683)	No ( n=3,078)
NYHA class III or IV
At 30 days	326/2,925 (11.1%)	48/527 (9.1%)	278/2,398 (11.6%)	0.10
At 6 months	211/2,227 (9.5%)	35/408 (8.6%)	176/1,819 (9.7%)	0.49
At 1 year	132/1,331 (9.9%)	19/268 (7.1%)	113/1,063 (10.6%)	0.08
Death
At 30 days
All cause mortality	361 (9.6%)	63 (9.2%)	298 (9.7%)	0.71
Cardiovascular mortality	243 (6.5%)	45 (6.6%)	198 (6.4%)	0.81
At 6 months
All cause mortality	632 (16.8%)	110 (16.1%)	522 (17.0%)	0.59
Cardiovascular mortality	379 (10.1%)	69 (10.1%)	310 (10.1%)	0.92
At 1 year
All cause mortality	752 (20.0%)	130 (19.0%)	622 (20.2%)	0.49
Cardiovascular mortality	453 (12.0%)	84 (12.3%)	369 (12.0%)	0.83

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