MedicalResearch.com Interview with:
Michael A. Gaglia Jr., MD, MSc, FACC, FSCAI
Scientific Lead, Population Research
Medstar Cardiovascular Research Network
Medstar Heart and Vascular Institute
Washington, DC 20010
MedicalResearch.com: What is the background for this study?
Response: Cardiovascular outcomes vary according to gender in a variety of disease states. For example, short-term mortality is higher among women presenting with an acute coronary syndrome in comparison to men. There is a similar trend for higher short-term mortality of women undergoing coronary artery bypass grafting, although this is in part due to a relatively higher burden of comorbidities. Female gender is also a well-established risk factor for bleeding complications after percutaneous coronary intervention.
In regards to women undergoing surgical aortic valve replacement for severe aortic stenosis (AS), however, the data is equivocal; some studies suggest higher mortality for women, whereas others suggest improved survival for women.
The emergence of transcatheter aortic valve replacement (TAVR) as the preferred therapeutic option for patients with severe AS at high or extreme risk for surgery offered another opportunity to examine gender disparities in outcomes. The evidence base for the impact of gender upon TAVR, however, is still evolving. A recent meta-analysis suggested improved long-term survival among women after TAVR. And in general, previous studies also suggest more vascular and bleeding complications in women when compared to men. The goal of this study was relatively simple: to compare outcomes between women and men undergoing TAVR at a single center.
MedicalResearch.com: What are the main findings?
Response: Our study had the following primary findings:
- 1) women undergoing TAVR suffer higher rates of short-term all-cause mortality, life-threatening bleeding, and iliofemoral complications requiring surgical or endovascular repair in comparison to men;
- 2) despite this, unadjusted survival at 1 year after TAVR was similar between women and men;
- 3) Transfemoral access for TAVR was associated with improved survival among both women and men;
- 4) And lastly, following multivariable adjustment, female gender was independently associated with lower mortality at 1 year after TAVR.
MedicalResearch.com: What should readers take away from your report?
Response: The primary lesson from this study is that despite higher rates of major bleeding, vascular complications, and 30-day mortality after TAVR, female gender was independently associated with improved survival at 1 year.
This is an intriguing finding because gender differences in long-term outcomes may also have a pathophysiological basis. For example, women demonstrate more left ventricular hypertrophy in response to aortic stenosis (AS), and more frequent resolution of hypertrophy after surgical aortic valve replacement, than men. Cardiac fibroblasts in women with AS also exhibit less collagen synthesis than men, and biopsy specimens show less endocardial fibrosis. These differences might explain, at least in part, gender differences in long-term survival.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: If the myocardium of women does indeed respond differently to aortic stenosis than that of men, then future research might focus upon gender differences in both pre- and post-TAVR biopsy samples.
Future studies might also focus upon the relative benefits of TAVR vs. surgical AVR in female patients. A separate question that is not addressed by our present study is the following: is TAVR superior to surgical AVR in high-risk women?
MedicalResearch.com: Is there anything else you would like to add?
Response: The present study also showed that iliofemoral vascular complications necessitating surgical or endovascular repair were clearly more common among women. This is at least in part explained by the smaller iliofemoral diameters observed in women. One would expect attenuation of this risk over time for two reasons.
- One, the learning curve for preventing and treating vascular complications is likely to be steep, with the impact of such vascular complications upon outcomes like mortality decreasing over time.
- Two, the profile of valve delivery systems has decreased over time; one would expect this to have the most impact upon women, given their smaller iliofemoral diameters at baseline.
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Comparison in Men Versus Women of Comorbidities, Complications, and Outcomes After Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis
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