Over the Long Haul, TAVR Appears Better Than Surgery for Women

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In women, transcatheter aortic valve replacement (TAVR)—particularly when performed via transfemoral access—is associated with lower risk of late mortality compared with surgery. However, men fail to experience the same long-term survival advantage with TAVR, according to a retrospective analysis of the PARTNER trial published online February 19, 2014, ahead of print in the Journal of the American College of Cardiology.

Susheel K. Kodali, MD, of Columbia University Medical Center (New York, NY), and colleagues reviewed data on the 699 high-risk patients (300 women) with symptomatic, severe aortic stenosis who took part in Cohort A of the PARTNER (Placement of AoRTic traNscathetER valves) trial. Patients were randomized to undergo either surgical replacement (n = 351) or TAVR (n = 348) with the Sapien aortic valve system (Edwards Lifesciences, Irvine, CA).

Women Have Lower All-Cause Mortality with TAVR at 2 Years

Baseline characteristics differed by sex. Women had higher mean Society of Thoracic Surgeons scores compared with men (11.9 vs 11.6; P = 0.05) but lower prevalence of CAD (64.4% vs 83.7%), peripheral vascular disease (36.4% vs 46.9%), diabetes (35.6% vs 45.6%), and elevated creatinine (11.7% vs 23.9%). In addition, women were less likely to have previously undergone CABG (19.8% vs 61.2%).

In women, TAVR was associated with a trend toward lower procedural (in-hospital or 30-day) mortality compared with surgery. Procedural stroke and vascular complications were more likely with TAVR, driven by differences in the transfemoral arm, though surgery was linked to higher bleeding. At both 6 months and 2 years, TAVR is associated with reduced all-cause mortality (table 1).

Table 1. PARTNER Cohort A: Women

 

TAVR

Surgery

P Value

Procedural Mortality

6.8%

13.1%

0.07

Procedural Stroke

5.4%

0.7%

0.02

Vascular Complications

15.0%

4.6%

< 0.01

Bleeding

10.9%

21.6%

0.01

All-Cause Mortality
6 Months
2 Years

 
12.2%
28.2%

 
25.8%
38.2%

 
< 0.01
0.049


At 2-year follow-up, the risk of all-cause mortality was one-third lower with TAVR (HR 0.67; 95% CI 0.44-1.00), a difference seen solely among women treated via transfemoral access (HR 0.55; 95% CI 0.32-0.93; P = 0.02).

Echocardiographic valve area was larger in women treated with TAVR compared with surgery (1.49 cm2 vs 1.35 cm2; P = 0.01). There was no difference in mean or peak gradient.

For men, procedural outcomes followed similar patterns, though there was no difference in stroke rates. In addition, the early mortality advantage with TAVR did not persist at 6 months or 2 years, whether the procedure was performed via transfemoral or transapical access (table 2). In fact, excluding procedural deaths, mortality among men was higher with TAVR than with surgery at 2 years (HR 1.58; 95% CI 1.06-2.36; P = 0.02).

Table 2. PARTNER Cohort A: Men

 

TAVR

Surgery

P Value

Procedural Mortality

6.0%

12.1%

0.03

Procedural Stroke

4.0%

4.0%

0.98

Vascular Complications

8.0%

2.5%

0.02

Bleeding

9.5%

21.1%

0.001

All-Cause Mortality
6 Months
2 Years

 
15.0%
37.7%

 
19.8%
32.3%

 
0.17
0.42


Again, echocardiographic valve area was larger with TAVR compared with surgery (1.71 cm2 vs 1.55 cm2; P < 0.01 with no differences in transaortic gradient.

Among TAVR patients, moderate or severe paravalvular aortic regurgitation (AR) was more common in men than in women (10.3% vs 3.0%; P = 0.03). The disparity is “perhaps due to more frequent undersizing of valves,” the authors suggest. “Because of the association of paravalvular AR with increased mortality, this may contribute to the lack of TAVR benefit seen in males and may be remedied by next-generation valves and better sizing algorithms.”

The current findings suggest that TAVR may be preferable to surgery in high-risk female patients, the investigators conclude. However, they caution that only a randomized controlled trial in women can fully answer the question.

Baseline Differences, Faster LV Mass Regression May Influence Outcome

Peter C. Block, MD, of Emory University School of Medicine (Atlanta, GA), agreed with the study authors that baseline differences may explain why women did so much better with TAVR than surgery over the long-term. “Perhaps long-term after TAVR these issues make a difference, or perhaps this is based on more complex issues (which I believe),” he told TCTMD in an e-mail. “However, the question not answered by this paper is more important—do women do better than men with TAVR?”

One reason for the sex difference relates to LV mass regression, Dr. Block said, citing 2 papers presented by Brian R. Lindman, MD, of the Washington University School of Medicine (St. Louis, MO), last fall at the American Heart Association Scientific Sessions in Dallas, TX.

One paper indicated that women appear to have faster LV mass regression than men, while the other showed that LV regression is associated with fewer repeat hospitalizations and better outcomes. In other words, he explained, “women, because they regress their LV faster [after TAVR], do better.”

Many more trials would be required to “prove all this, but the data surely point to the [idea] that TAVR might just be the right choice for women with aortic stenosis,” Dr. Block concluded.

Stephen G. Ellis, MD, of the Cleveland Clinic (Cleveland, OH), also emphasized the importance of baseline differences.

“I think as a general observation, women who can have transfemoral TAVR are healthier than women who require transapical TAVR or men considered for either procedure,” Dr. Ellis commented in an email with TCTMD. “They are much more likely to have aortic stenosis as their overwhelmingly major problem. So if/when you get them through the procedure (and we’re getting much better at that), they will do well.”

“Clearly every patient is different,” he continued, “and they are best off when we consider their particular situation. But unlike in many cardiac surgery procedures, being female does not seem to be a risk factor for TAVR.”

Unfortunately, Dr. Ellis said, a dedicated trial in women is unlikely.

Note: Dr. Kodali and several coauthors of the study are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Source:
Williams M, Kodali SK, Hahn RT, et al. Sex-related differences in outcomes following transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: insights from the PARTNER trial. J Am Coll Cardiol. 2014;Epub ahead of print.

 

  • Dr. Kodali reports serving as a consultant to the PARTNER trial steering committee, on the steering committee of the Portico trial, and on the scientific advisory board of Thubrikar Aortic Valve.
  • Drs. Block and Ellis report no relevant conflicts of interest.

 

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Disclosures
  • The PARTNER trial was funded by Edwards Lifesciences.

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