Author + information
- Loïc Bière, MD∗ (, )
- Marie Launay, MD,
- Frédéric Pinaud, MD, PhD,
- Jean-François Hamel, MD,
- Hélène Eltchaninoff, MD,
- Bernard Iung, MD, PhD,
- Marc Laskar, MD,
- Alain Leguerrier, MD, PhD,
- Martine Gilard, MD, PhD and
- Alain Furber, MD, PhD
- ↵∗Laboratoire cardioprotection, remodelage et thrombose, UPRES EA 3860, Faculté de Médecine, rue Haute de Reculée, FR-49045 Angers Cedex, France
Transcatheter aortic valve replacement (TAVR) is an alternative to surgery for high-risk or inoperable patients (1). However, few data, with varied and confusing follow-up timings, are available (2,3) concerning sex related differences in post-TAVR patients.
We sought to clarify the independent impact of sex on cardiovascular outcomes in patients who underwent TAVR and were included in the FRANCE 2 (French Aortic National CoreValve and Edwards) registry (1). The study design and procedures have been described previously (1).
The 3,972 patients who underwent TAVR in French centers between January 2010 and January 2012 were prospectively included into the registry. Overall, 1,967 were women (49.5%).
Quantitative and qualitative variables were compared using unpaired Student t test or chi-square test, respectively. Cox regression models were applied for explaining 1-month and 1-month to 1-year mortality, and the combined safety endpoint that comprised a composite of all-cause mortality, stroke, life-threatening bleeding, acute renal failure, periprocedural myocardial infarction, major vascular complication, and the need for repeating the procedure at 1 month. We tested specific interactions between sex and either EuroSCORE, renal failure, coronary artery disease, or moderate to severe post-procedural aortic regurgitation. Significant interactions were included into the Cox models. Statistical significance was set at p < 0.05.
Women presented with fewer comorbidities but similar logistic EuroSCORE (Table 1), exhibiting more often a history of congestive heart failure (43.7% vs. 39.7%; p = 0.001), but less often a history of angina (14.5% vs. 17.0%; p = 0.032).
The absolute 1-month mortality was similar in men and women (Table 1). A significant interaction between sex and EuroSCORE was clearly distinguished, with a higher EuroSCORE proving predictive of excessive mortality solely in male patients (hazard ratio [HR]: 3.44 [95% confidence interval (CI): 1.77 to 6.69]; p < 0.001). In this model, female sex was found to produce an HR of 2.59 [95% CI: 1.30 to 5.17] (p = 0.013). The other independent predictors for 1-month mortality were as follows: transapical approach (HR: 1.78 [95% CI: 1.10–2.87]; p = 0.020); moderate to severe post-procedural aortic regurgitation (HR: 2.46 [95% CI: 1.57–3.85]; p < 0.001).
Women presented with lower 1-year mortality (19.3% vs. 23.7%; p = 0.021). Independent predictors of 1-month to 1-year mortality were female sex (HR: 0.71 [95% CI: 0.57 to 0.88]; p < 0.002), age >85 years (HR: 1.29 [95% CI: 1.04 to 1.59]; p = 0.020), EuroSCORE (HR: 1.36 [95% CI: 1.09 to 1.68]; p = 0.006), hostile thorax (HR: 1.42 [95% CI: 1.10 to 1.83]; p = 0.007), New York Heart Association functional class III or IV (HR: 1.43 [95% CI: 1.10 to1.86]; p = 0.008), renal failure (HR: 1.86 [95% CI: 1.38 to 2.52]; p < 0.001), and moderate to severe post-procedural aortic regurgitation (HR: 1.68 [95% CI: 1.32 to 2.16]; p < 0.001). No significant interaction was detected.
Female sex was not an independent predictor of the composite safety endpoint (HR: 1.20 [95% CI: 0.99 to 1.46]; p = 0.06). Female patients presented, however, with higher rates of iliofemoral dissection or rupture (5.6% vs. 2.2%; p < 0.001). Both female and male patients displayed similar changes in New York Heart Association functional class and low stroke rates (3.1% vs. 2.2%; p = 0.11).
The FRANCE 2 registry reported more frequent use of post-procedural pacemaker implantation in men (3), while more women had higher rates with the balloon-expandable valve (Sapien, Edwards Lifesciences, Irvine, California), which may illustrate the impact of balloon expansion in smaller aortic roots.
After multiple adjustments, we found the male sex to be a predictive factor of 1-month to 1-year mortality. Our report is the first large study to corroborate such insight of the literature (2,3). Although aortic stenosis affects both sexes equally (4), the limited use of TAVR in female patients (“only” 49.5% of the cohort) is somewhat confusing, given their naturally longer life expectancy. This paradox had already been confirmed in valvular surgery (5). Women should, in fact, receive a higher rate of TAVR procedures, which could further enhance its cost-effectiveness.
In conclusion, our study provides evidence of the numerous imbalances in baseline characteristics and outcomes that exist between sexes. The lower 1-year mortality in women remained significant after adjustment for confounders. The logistic EuroSCORE was not a good predictor of mortality and appeared unsuitable for 1-month prognosis estimation in female patients. This underlines the usefulness of drawing up a specific risk score for complications and mortality in TAVR patients, notably one that includes sex.
Please note: Dr. Eltchaninoff has served as a proctor for Edwards Lifesciences. Dr. Iung has served as a consultant for Abbott, Boehringer Ingelheim, and Valtech; and has received speakers fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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