Does Sex Matter in Transcatheter Aortic Valve Therapy Outcomes?
Although female patients experienced higher in-hospital vascular complications, their overall 1-year survival rates were better.
Female patients undergoing transcatheter aortic valve replacement (TAVR) procedures experience elevated 1-year survival rates vs male patients, according to research published in the Journal of the American College of Cardiology.1
Roxana Mehran, MD, from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry to compare results among female (49.9% of study population) and male (51.1%) TAVR patients.
Primary study end points were assessed both in-hospital and at 1 year. In-hospital events included all-cause death, myocardial infarction (MI), stroke, major bleeding, and major vascular complications (defined by the Vascular Academic Research Consortium-2 definition). One-year end points included time to event occurrence of death, MI, stroke, and clinically significant bleeding. Composite end points included major adverse cardiac events (MACE), death or stroke, death or MI, and a composite of MACE or clinically significant bleeding.
Between 2011 and 2014, more than 11,000 women and nearly 12,000 men underwent TAVR procedures. The female patients were older and had lower rates of coronary artery disease, atrial fibrillation, and diabetes, but higher rates of porcelain aorta and higher mean Society of Thoracic Surgeons scores. Female patients also had higher mean left ventricular ejection fraction and higher rates of moderate or severe mitral valve regurgitation and New York Heart Association (NYHA) functional class III or IV heart failure.
Among study participants, TAVR was most commonly performed as a result of degenerative aortic valve disease (94.5%). Of those procedures, 3.2% of patients had severe aortic insufficiency and 1.9% had bicuspid aortic stenosis.
More often, female patients underwent TAVR via nontransfemoral access (45% vs 35%); median sheath size was 22 F (24 F in male patients), and females typically received smaller valve sizes. A majority of devices were older-generation devices, and balloon-expandable TAVR was more frequently used than self-expanding TAVR (87% vs 13%), with no sex-based difference.
Postdischarge, male patients were more likely to use aspirin (88.7% vs 87.1%; P =.0028), P2Y12 receptor inhibitors (63.8% vs 62.0%; P =.02), and dual antiplatelet therapy (57.4% vs 55.1%; P =.0004) than female patients.
Investigators found no difference in rate of device success, postimplant aortic valve gradient, or postimplant aortic valve area in either group. Complications were rare, but occurred more frequently in female patients. In addition, female patients were more likely to have the procedure aborted as a result of access- or navigation-related issues, or to convert to open surgery or emergent cardiopulmonary bypass.
Female patients experienced higher rates of in-hospital vascular complications (8.3% vs 4.4%; adjusted hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.34-2.14; P <.001) and more bleeding (8% vs 6%; adjusted HR, 1.19; 95% CI, 0.99-1.44; P =.06). No difference was identified in incidence of death, MI, stroke, or MACE. In-hospital net adverse cardiac events were "numerically higher" in females vs males (19.0% vs 13.8%; adjusted HR, 1.14; 95% CI, 0.99-1.30; P =.06).
At 1 year, female patients had higher rates of survival (78.7% vs 75.5%; adjusted HR, 0.73; 95% CI, 0.63-0.85; P <.001) and lower rates of MACE, composite death or MI, and death or stroke compared with male patients (25.3% vs 28.1% [adjusted HR, 0.80; 95% CI, 0.70-0.92; P =.0012]; 22.7% vs 26.2% [adjusted HR, 0.74; 95% CI, 0.64-0.85; P <.001]; and 24.2% vs 26.6% [adjusted HR, 0.80; 95% CI, 0.70-0.92; P <.001], respectively).
"Female patients undergoing TAVR for significant aortic valve disease have a different risk profile compared with male patients," the researchers concluded. "Notwithstanding a greater adjusted risk for in-hospital vascular complications, 1-year survival was superior in female patients compared with male patients."
In an accompanying Journal of American College of Cardiology editorial,2 Molly Szerlip, MD, from the Department of Interventional Cardiology at The Heart Hospital Baylor Plano in Texas, noted that the results of the study should be cautiously interpreted. "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," she wrote.
Citing the sex-specific results found in the high- and intermediate-risk cohorts in the Placement of Aortic Transcatheter Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (PARTNER 2 S3iCAP) trial,3 Dr Szerlip added, "there was no difference at 1 year in survival or any other major outcome between female and male patients despite a continued higher incidence in procedural vascular complications in female patients."
Limitations and Disclosures
- Findings are based on observational registry data, which were internally validated but not centrally adjudicated.
- One-year data, drawn from claims records, may underestimate the occurrence of certain events.
- Unmeasured confounders may account for biased reporting of 1-year survival.
- The researchers did not examine different outcomes based on TAVR period or make adjustments for device types.
- Sex-based differences may be attenuated with contemporary technologies.
Dr Vemulapalli reports receiving research grant support from Abbot Vascular and consulting fees from Novella. Dr Mehran reports receiving research grant support from Eli Lilly/DSI, AstraZeneca, The Medicines Company, Bristol-Myers Squibb, OrbusNeich, Bayer, and CSL Behring, as well as consulting fees from Janssen Pharmaceuticals Inc, Medscape, Osprey Medical Inc, and Watermak Research Partners. Dr Mehran also reports having served on the scientific advisory board of Abbott Laboratories. Dr Szerlip served as a guest editor of the paper.
- Chandrasekhar J, Dangas G, Yu J, et al, for the STS/TVT Registry. Sex-based differences in outcomes with transcatheter aortic valve therapy. TVT registry from 2011 to 2014. J Am Coll Cardiol. 2016;68:2733-2744. doi: 10.1016/j.jacc.2016.10.041
- Szerlip M. Transcatheter aortic valve replacement. Only one of the advantages of being female. J Am Coll Cardiol. 2016;68:2745-2746. doi: 10.1016.j.jacc.2016.10.042
- Szerlip M, Gualano S, Squires J. TCT-674 Sex specific outcomes of TAVR with the Sapien 3 valve: insights from the PARTNER 2 S3 high-risk and intermediate-risk cohorts. J Am Coll Cardiol. 2016;68:B272-B273. doi: 10.1016/j.jacc.2016.09.087