Women Benefit From TAVR as Much as Men, Maybe More

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Despite different baseline and anatomical characteristics, women with severe aortic stenosis show equivalent short-term benefits from transcatheter aortic valve replacement (TAVR) compared with men, with higher 1-year survival rates. The prospective registry study appears in the February 7, 2012, issue of the Journal of the American College of Cardiology.

Marie-Claude Morice, MD, of Institut Cardiovasculaire Paris Sud (Massy, France), and colleagues followed 260 patients (131 female, 129 male) who underwent TAVR at their institution between October 2006 and December 2010 to identify sex differences in clinical presentation and predictors of mortality.

Overall device success was 89.6%, with no sex-related differences. Neither were there differences in major complications, aortic pressure gradient, aortic regurgitation, 30 day mortality, or the combined 30-day VARC safety endpoint (table 1).

Table 1. Postprocedural Complications and Outcomes

^a All-cause mortality, major stroke, life-threatening (or disabling) bleeding, acute kidney injury—stage 3 (including renal replacement therapy), periprocedural MI, major vascular  complication, or repeat procedure for valve-related dysfunction.

There were some differences such as higher rates of iliac complications among women (9.0% vs. 2.5%; P = 0.030). Females also had higher postprocedural LVEF than men (56.8% vs. 51.0%; P < 0.001), as they did prior to TAVR.  In addition, 1-year survival was higher among women (76% vs. 65%; P = 0.037). Male sex was an independent predictor of mid-term mortality on regression analysis (HR 1.62; 95% CI 1.03-2.53; P = 0.037).

Women Healthier Than Men

Women were slightly older than men in the study (83.8 vs. 82.4 years; P = 0.080), with roughly half the level of coronary disease, PAD, and previous cardiac surgery compared to men, in addition to higher LVEF (53.5% vs. 47.1%; P < 0.001) and lower logistic EuroScore (22.3% vs. 26.2%; P = 0.005).

Aortic valve area was similar between men and women, but women had a smaller annulus (20.9 mm vs. 22.9 mm; P < 0.001) and bioprosthesis size (23.9 mm vs. 26.3 mm; P < 0.001). Women more often received an Edwards Sapien valve (Edwards Lifesciences, Irvine, CA) compared with men (91.6% vs. 79.1%; P = 0.005).

Claiming that the study represents the first detailed description of sex-related differences in severe aortic stenosis patients undergoing TAVR, Dr. Morice and colleagues note that, “Female sex was associated with lower comorbidities and a lower EuroSCORE.” They add that despite smaller body size in women and other anatomical differences, “similar device success was achieved in women and men alike with adequate reduction in the transprosthetic pressure gradient. Although no relation with the 30-day mortality rate was observed, female sex was associated with better midterm survival after TAVI.”

TAVR Findings Contrast with Surgical Replacement

The researchers add that the lack of worse outcomes in women undergoing TAVR is strikingly different from surgical aortic valve replacement (AVR), where certain studies have shown an increased short-term mortality with women and identified female sex as a predictor of perioperative mortality following cardiac surgery.

According to Dr. Morice, the researchers were surprised by the results. “Yes, I thought the outcome [would be] worse in females because of the smaller iliac arteries with the potential risk of femoral complications,” she told TCTMD in an e-mail communication.

One of the clear implications from the study, she continued, is that despite some worse anatomical characteristics, women are still doing just as well as men with TAVR. “This is an important message, especially because women have a longer life expectancy than men,” Dr. Morice said. “This makes the procedure even more cost effective.”

Sex Differences Clear, Questions Remain

“This is the beginning of an effort to unravel why there’s this difference between surgical AVR, where women have higher procedural mortality, and TAVR, where it seems to be the opposite,” commented Ted Feldman, MD, of Evanston Hospital (Evanston, IL), in a telephone interview with TCTMD.

He added that while the study shows some clear differences between men and women, the findings raise some key questions. “Women’s ventricles are better and they have less coronary disease, but why?” Dr. Feldman asked. “Is it a selection phenomenon, or some fundamental difference in how the disease works in men compared with women? That remains the unanswerable question at this point.”

Regardless, the findings can help clinicians in dealing with potential TAVR patients. “It does help with the way you talk with your patient preprocedurally,” Dr. Feldman said. “That is, the more we understand their probable outcomes, the better we can talk to them about what to expect.”

Dr. Morice noted that clinicians should use the findings to “take into consideration the gender for planning TAVI, selecting the valve and size, and preventing specific complications.”

The study also helps combat an unfortunate trend regarding women and cardiovascular clinical trials. “The proportion of women in all the TAVR experience is roughly 50-50, or even a little in favor of women,” Dr. Feldman said. “In contrast, in coronary disease, it’s about 75-25 in favor of men.”

Dr. Morice agreed, commenting that, “For once, in a clinical trial, women are not an underrepresented subgroup.”

Study Details

The Sapien or Sapien XT valves were used in the majority of cases (n = 222) with the CoreValve system (Medtronic, Minneapolis, MN) used less often (n = 38).

 

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Source:
Hayashida K, Morice MC, Chevalier B, et al. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012;59:566-571.

 

Disclosures:

• Dr. Morice reports no relevant conflicts of interest.
• Dr. Feldman reports serving as a consultant for Abbott Vascular, Boston Scientific, and Edwards Lifesciences.

 

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