Methods

The present analysis includes all patients treated with TAVI enrolled from January 2010 to December 2011 in the FRANCE 2 registry. We analyzed baseline characteristics and VARC outcomes during procedure, at 30 days, and at 1 year, for patients according to the presence or absence of concomitant COPD. The existence of COPD was defined by the clinical definition as the presence of lung symptoms (e.g., progressive dyspnea, cough, wheezing, or sputum production) requiring long-term use of bronchodilators or steroids.

The FRANCE 2 registry is a multicenter prospective registry including 33 centers in France and 1 in Monaco. Details of the registry have previously been described. Briefly, patients included in the registry were symptomatic adults with severe aortic stenosis who were not candidates for surgical aortic valve replacement because of coexisting illness. Severe aortic stenosis was defined as an aortic valve area of <0.8 cm ² , a mean aortic valve gradient of ≥40 mm Hg, or a peak aortic jet velocity of ≥4.0 m/s. All patients had New York Heart Association (NYHA) class II, III, or IV symptoms.

Continuous variables are expressed as mean ± SD when normally distributed or median (interquartile range) if not normally distributed and were analyzed with the Student t test or Wilcoxon rank sum test, as appropriate. Categorical variables are described as number (percentage) and were compared with the chi-square test or Fisher’s exact test, as appropriate. To evaluate the relation between the presence of COPD and outcomes, we performed the following analyses. First, to identify predictors of all-cause mortality and combined safety end point at 30 days and all-cause mortality and combined efficacy end point at 1 year in the whole population, we used a multivariate Cox proportional hazards model including baseline variables with p value <0.05 by univariate Cox regression analysis. Results are reported as hazard ratio (HR) with associated 95% confidence interval (CI) and p value. Interactions between COPD and gender, peripheral artery disease, diabetes mellitus, chronic renal failure, low ejection fraction (≤35%), pulmonary hypertension, type of anesthesia, femoral access, and type of device implanted were tested by the Breslow-Day test in the whole population. Next, to reduce treatment selection bias and potential confounding, we performed propensity score matching. The propensity score (propensity to have COPD) was calculated by performing a multivariate logistic regression with COPD as the dependent variable. The following covariables were selected: age, gender, NYHA class III or IV, hypertension, diabetes mellitus, coronary artery disease, previous myocardial infarction, previous coronary artery bypass graft, peripheral vascular disease, chronic kidney disease, previous stroke, atrial fibrillation, porcelain aorta, left ventricular ejection fraction ≤35%, pulmonary hypertension, type of access, type of anesthesia, and type of valve. Subjects were matched on the first 8 figures of propensity score. A standardized difference of <0.015 was considered acceptable. VARC-defined outcomes in the unmatched population were analyzed with Cox proportional hazards regression and with the log-rank test in the matched population. Survival was estimated by the Kaplan-Meier method. A p value of <0.05 was considered statistically significant. All statistical analyses were performed with SAS, version 9.3 (SAS Institute Inc., Cary, North Carolina).

Results

A total of 3,933 patients were treated with TAVI in France from January 2010 to December 2011 and included in the current analysis. No patient was lost to follow-up. Overall, 895 patients (22.7%) had concomitant COPD and 3,038 (77.3%) had no concomitant COPD. The baseline characteristics of the whole population are listed in Table 1 . Patients with COPD were more frequently men and were also significantly younger. Significant differences between the 2 groups were observed for the following major co-morbidities: diabetes mellitus, peripheral arterial disease, history of stroke, history of coronary artery disease, and previous coronary artery bypass graft. Moreover, heart failure symptoms were more common in patients with concomitant COPD ( Table 1 ).

The rate of general and local anesthesia did not differ between the COPD and non-COPD groups. The transfemoral access route was the most commonly used approach, both in patients with and in those without COPD. Similarly, there was no difference in the rate of use of transapical and transaortic routes between groups. Conversely, trans-subclavian access was used more frequently in patients with COPD than in those without. Finally, the rate of significant postprocedural aortic regurgitation (grade ≥2 or 4) was similar in both groups.

VARC-defined outcomes in the whole population are summarized in Table 2 . The device was successful in 865 patients (96.6%) with COPD and in 2,932 patients (96.5%) without COPD. Immediate postprocedural mortality rate was 4.1% (37 patients) in the COPD group and 3.6% (109 patients) in the non-COPD group. At 30 days, there was no significant difference in mortality rate or in the other VARC-defined complications, although we observed a borderline significant tendency toward higher all-cause mortality rate in the COPD group.

At 1 year, the all-cause mortality rate and the combined efficacy end point were significantly higher in patients with concomitant COPD compared with patients without concomitant COPD. Figure 1 and Figure 2 illustrate the survival probability curves and the event-free survival probability curves, respectively, in the unmatched population. NYHA functional class was likewise significantly higher in the COPD group ( Figure 3 ). Finally, the other VARC-defined outcomes at 1 year, including stroke, rehospitalization for valve-related symptoms or worsening congestive heart failure, and valve-related dysfunction were similar between groups.

Kaplan-Meier curves of 1-year survival probability in patients with and without concomitant COPD.

Kaplan-Meier curves of 1-year, free from combined efficacy end point, survival probability in patients with and without concomitant COPD.

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