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One-year TAVR outcomes superior in women vs. men
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Compared with men, women undergoing transcatheter aortic valve replacement for significant aortic valve disease have superior 1-year survival, although they have a greater adjusted risk for in-hospital vascular complications, according to recent findings.
In the study, researchers evaluated national data on 23,652 patients who underwent TAVR enrolled in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) registry between November 2011 and September 2014. The STS/ACC TVT registry includes comprehensive data on patients who received TAVR, including baseline information, 30-day and 1-year follow-up data. Data from the registry were linked from Medicare administrative claims for identification of events necessitating hospitalization.
Jaya Chandrasekhar, MBBS, MRCP, FRACP, from Icahn School of Medicine at Mount Sinai, and colleagues evaluated endpoints in the hospital and at 1 year. In-hospital events included all-cause death, MI, stroke, major bleeding and major vascular complications based on the Valve Academic Research Consortium (VARC)-2 criteria.
MACE was defined as the composite of death, MI or stroke, and net adverse cardiac events were defined as the composite of in-hospital MACE, major bleeding or major vascular complication. Composite death or stroke and death or MI were also designated as endpoints. One-year individual endpoints included time to event occurrence of death, MI, stroke and clinically significant bleeding. The researchers compared outcomes between the 11,808 female patients (49.9%) and 11,844 (51.1%) male patients.
Differences by sex
Chandrasekhar and colleagues found that female patients undergoing TAVR tended to be somewhat older than men and had lower rates of previous percutaneous (29.5% vs. 41.9%) or surgical (16.4% vs. 46.1%) coronary revascularization. Women also had lower rates of atrial fibrillation (38.94% vs. 42.7%), diabetes (35% vs. 39.5%), lung disease (12.9% vs. 14.6%) and lower glomerular filtration rate (61.2 mL/min vs. 63.3 mL/min) but had a higher prevalence of porcelain aorta (7.7% vs. 6%; P < .001 for all). Female patients had a mean STS Predicted Risk of Mortality score of 9% vs. 8% for male patients (P < .001).
Women more frequently underwent TAVR using nontransfemoral access (45% vs. 35%) and surgical cutdown (36.8% vs. 32.4%) vs. male patients. Female patients had a median sheath size of 22F vs. a median sheath size of 24F in men, according to the findings.
Female patients more often attained valve cover index ≥ 8% (65.7% vs. 53.9%). There was a comparable reported incidence of residual severe aortic incompetence in women and men (3.4% vs. 3.1%).
The researchers found no difference between men and women in the rate of device success, postimplant aortic valve gradient or post-implant aortic valve area. Although complications pertaining to device implantation were rare, they occurred more frequently in female patients.
There was a higher incidence of in-hospital vascular complications in female patients vs. male patients (8.3% vs. 4.4%; adjusted HR = 1.7; 95% CI, 1.34-2.14), and female patients demonstrated a trend toward more bleeding (8% vs. 6%; adjusted HR = 1.19; 95% CI, 0.99-1.44). No difference was seen in women vs. men in terms of procedural or in-hospital death, MI, stroke or MACE. Women had a numerically higher prevalence of net adverse cardiac events vs. men (19% vs. 13.8%; adjusted HR = 1.14; 95% CI, 0.99-1.3).
At 1 year, mortality was lower in women vs. men (21.3% vs. 24.5%; adjusted HR = 0.73; 95% CI, 0.63-0.85), according to the researchers.
The results were consistent with an analysis of selected patients from the TVT registry from 2012 to 2014 presented by Chandrasekhar at the Society for Cardiovascular Angiography and Interventions Scientific Sessions in May.
Interpret with caution
In a related editorial, Molly Szerlip, MD, of the department of interventional cardiology at The Heart Hospital Baylor Plano, Texas, wrote that although these findings are noteworthy, they should be interpreted 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,” Szerlip wrote. “We recently reported sex-specific outcomes of TAVR in the PARTNER IIA S3 high-risk and intermediate-risk cohorts at the 2016 Transcatheter Cardiovascular Therapeutics conference. In this high-risk and intermediate-risk cohort, 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.” – by Jennifer Byrne
Disclosure: Chandrasekhar reports no relevant financial disclosures. Please see the full study for a list of the other researchers’ relevant financial disclosures. Szerlip reports speaking for Abbott Vascular and Edwards Lifesciences, proctoring for Edwards Lifesciences and consulting for Medtronic.
Perspective
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Anita Asgar, MD, FRCPC, FACC
This study clearly shows that in real-world patients treated with TAVR, women comprise almost 50% of patients treated. They tend to be older but in this study had comparable STS risk scores despite having lower rates of significant comorbidities such as diabetes and ischemic heart disease, chronic obstructive pulmonary disease and peripheral vascular disease. This reflects an important limitation of the STS score.
The most interesting point is that more women required alternative access than men, including surgical cutdown, despite having an indication for a smaller valve size. In addition, there were more vascular complications and bleeding, though the bleeding complications could be related to the higher rate of alternative access. Despite this, at 1 year women had better survival than men, likely as a result of fewer comorbidities.
It is important to remember that these data represent practice in 2011 to 2014, with predominantly balloon-expandable systems and first-generation devices that were larger and required larger vessel sizes. It is unclear to me whether such results can be generalizable to present day, when the systems used range from 14F to 18F rather than 22F to 25F. In addition, the availability of such systems will likely result in less alternative access and fewer vascular complications and requirement for surgical cutdown. As was shown in BRAVO 3 gender substudy, which was a transfemoral study, there were marginal differences between men and women in vascular and bleeding complications, suggesting that access site may be even more important for women.
We need contemporary data with newer devices to understand the impact of smaller systems on complications and procedural outcomes in women. I would have liked to see an analysis of men and women treated via transfemoral access in the TVT registry to see if there was a difference in complications.
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