Courtesy of Dr. Carlos Fava.
The benefits of transcatheter aortic valve implantation (TAVI) have been widely shown, but there is no evidence on sex-specific outcomes. Some studies have shown lower mortality and better evolution of the ventricular function in women, yet with more bleeding and stroke; however, it remains unclear.
This study included 1,019 patients of 82.5 mean age, with 17.8 EuroSCORE I and 8.3 STS score. 26% of patients presented diabetes and 30.8% kidney failure.
71% presented three of more high risk criteria, the most frequent being age ≥80 and fragility.
Aortic annulus was 21.8 mm and ejection fraction was 55%. The angiography showed no obstructive disease in 62% of patients, left main disease in 7.5% and triple vessel disease in 10.4%.
738 patients (72.4%) had a history of pregnancy, only 31 with associated complications.
17.5% had osteoporosis and one third of them had been treated. 10% was associated with frailty and osteoporosis.
Breast and gynecologic cancer rates were 9.3% and 2.3% respectively.
90.6% of procedures used the femoral access site, the preferred valve was the CoreValve (47.2%), followed by the Sapiens (41.7%). 42.1% of patients received second generation valves.
Results at 30 days were:
- Combined safety end point VARC-2: 14%.
- All-cause mortality: 3.4%.
- Cardiac death: 3.3%.
- Stroke: 1.3%.
- Major vascular complication: 7.7%.
- Major bleeding: 4.4%.
- Coronary obstruction: 0.7%.
- Need of second valve: 1.7%.
- Conversion to surgery: 0.7%.
- Need of definite pacemaker: 12.1%.
- Aortic regurgitation ≥2: 1.4%.
- Aortic regurgitation ≥3: 1.9%.
Event predictors were prior stroke, high STS score and <30% ejection fraction, while prior pregnancy was associated to lower events rate at 30 days.
Conclusion
This is the first all-female registry on TAVI with specific information about women at intermediate-high risk, at 30 days. VARC-2 final safety end point was 14% with low mortality and stroke at 30 days. Randomized studies on TAVI vs. surgery on intermediate risk patients are necessary.
Editorial Comment
This is the first registry with an important number of patients that show TAVI is safe for women. It looks into female specific characteristics and shows pregnancy has a protective effect. This should be analyzed in larger studies.
Original Title: Acute and 30-days Outcomes in Women after TAVR. Results from the WIN-TAVI (Women´s International Transcatheter Aortic Valve Implantation) Real-World Registry.
Reference: Alaide Chieffo, et al J Am Coll Cardiol interv 2016;9:1589-600
Courtesy of Dr. Carlos Fava. Favaloro Foundation, Buenos Aires, Argentina.
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