WIN TAVI: The Largest Female TAVR Registry So Far

Courtesy of Dr. Carlos Fava.

In most randomized or observational studies, women comprise more than 50% of patients undergoing TAVR, and they have showed better evolution, compared against surgery. The main differences between men and women with severe aortic stenosis are that women have smaller annular dimension, shorter distance to coronary ostia, smaller peripheral arteries, and higher osteoporosis, frailty, bleeding and cardiac failure rates.

The study looked at 1019 women undergoing TAVR in 18 centers in Europe and the US.

Read also: “Coronary Artery Dissection in Women: Rare and Difficult to Manage”.

Mean age was 82.5 years, 26.1% of patients were diabetic, 30.8% had kidney failure, 22.9% presented prior left main PCI, 20% had atrial fibrillation, 7.5% prior stroke and 9% peripheral vascular disease. Ejection fraction was 55.7%.

72.4% had a history of pregnancy. Patients with no history of pregnancy resulted more fragile (70% vs. 61.3% p=0.001), more had a history of smoking (5.4% vs. 2.5% p=0.02) and more left main compromise (8.7% vs. 4.6% p=0.06).

EuroSCORE I was 17.8±11.7% and STS was 8.3±7.4%.

Read also: “Sex Specific Outcomes: Women after TAVI”.

Procedure was performed under local anesthesia or conscious sedation in 64.2% of cases and 90% was by femoral access. Second generation valves were used in 42.1% of patients.

The combined efficacy end point VARC-2 over 30 days was10.9%, and 16.5% at one year. The combined end point of death or stroke at one year was 13.9%, cardiac death was 10.6%, and stroke was 2.2%. Vascular complications were 8.2% and the rate of death threatening bleeding was 4.5% (VARC criteria).

The presence of moderate to severe paravalvular leak by echo-Doppler was 9.7%; the number of arrhythmias or new vascular complications was 22.8%; new atrial fibrillation was 3.6% and need of definite pacemaker was 12.7%. 3.2 % of patients were readmitted for cardiac failure or valve related symptoms.

Read also: “Critical Lower Limb Ischemia Should Be Taken into Account in TAVR”.

Women with a history of pregnancy presented lower tendency to death and stroke.

Death and stroke predictors at one year were EuroSCORE I, prior PCI and new atrial fibrillation.

Conclusion

This is the first contemporary registry enrolling women at high or intermediate risk for TAVR. At one year, it presented 16.5% VARC 2 efficacy combined end point, where EuroSCORE I, atrial fibrillation and prior PCI were predictors of death and stroke at one  year. 

Commentary

This is the first contemporary registry to enroll women undergoing TAVR, and it shows this is a safe and effective strategy (despite baseline and morphological female features are different than those of men).

Also worth noting is that it is acceptable in women at high risk of vascular complications and bleeding, and that the presence of leaks is low (especially taking into account that less than half received second generation valves).

Courtesy of Dr. Carlos Fava.

Original title: 1-Year clinical outcome in Women After Transcatheter Aortic Valve Replacement Results from the First WIN-TAVI Registry.

Reference: Alaide Chieffo, et al. JACC Cardiovas Interv 2018;11:1-12.

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