TVT Registry Analysis Comparing TAVR Outcomes in Women Versus Men Published

December 22, 2016—The American College of Cardiology announced the publication of findings from a study demonstrating that the 1-year survival rate of women with significant aortic valve disease who undergo transcatheter aortic valve replacement (TAVR) is higher than in men, although women are considered higher risk than men in some respects, and have more complications (especially bleeding and vascular issues) as a result of the TAVR procedure. However, the reasons for this are not yet completely understood. This is the largest study to take an in-depth look at the longer-term outcomes and survival rates after TAVR in women and men, noted ACC.

The study was published by Jaya Chandrasekhar, MD, et al in the Journal of the American College of Cardiology (2016;68:2733–2744). In May 2016, the findings from this analysis were presented at the Society for Cardiovascular Angiography and Interventions 2016 scientific sessions in Orlando, Florida.

Roxana Mehran, MD, who is the Senior Investigator of the study, commented in the ACC announcement, "These findings are significant because it may mean heart teams are overestimating the risks of TAVR in some women and that also may mean that valve replacement is underutilized. In other words, some women who could benefit from TAVR may not be getting it." Dr. Mehran is a Professor of Medicine in Cardiology at The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai in New York, New York.

Dr. Mehran, continued, "These study results also highlight that we need a robust scoring assessment that is specific to TAVR and catered to women so we can make the best decisions. Additionally, further study is needed on the medium- to long-term causes of death in men and women who have had TAVR, particularly studies that are focused on learning more about vascular biology and why the aorta becomes more calcified in women."

Dr. Mehran also advised that there are promising advances being made in three-dimensional printing technology that will improve devices used in TAVR; as a result of improved technology, outcomes will likely further improve in both men and women.

Molly Szerlip, MD, addressed the study's findings in an accompanying editorial in Journal of the American College of Cardiology (2016;68:2745–2746). Dr. Szerlip, who is a cardiologist at The Heart Hospital Baylor Plano in Plano, Texas, stated in the editorial, "One should, however, interpret the results of this study with caution. The findings of this study are only applicable to the population that was studied and should not necessarily be extrapolated to lower risk populations or to patients who receive newer generation valves." 

As summarized in the ACC press release, the investigators used data from the Society of Thoracic Surgeon/American College of Cardiology Transcatheter Valve Therapy Registry to study more than 23,000 patients receiving TAVR with older generation devices between 2011 and 2014 with an almost equal proportion of women (49.9%) and men (51.1%).

In general, the women were older and had higher predicted 30-day risk scores. However, they were more likely to have other health issues at baseline, such as worsened kidney function, significant problems related to a leaking mitral heart valve, and heavily calcified (or "porcelain") aorta.

Men were more likely to be treated with percutaneous TAVR. Women were more likely to have a surgical incision for TAVR. Additionally, although very rare, there was a greater chance in women than in men that the operating cardiologist or surgeon would need to abort TAVR and switch over to open surgery due to complications.

Overall, women had more procedural problems but they had better survival at 1 year. In addition, with smaller and improved TAVR devices, women can increasingly undergo procedures percutaneously via the smaller artery in the groin, which would be expected to reduce the risk of procedural complications as well, reported ACC.