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WIN-TAVI registry highlights TAVR safety, performance in women
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New data from the first all-female transcatheter aortic valve replacement registry reveal that most women were considered high risk, nearly three-quarters were aged older than 80 years, and the 30-day VARC-2 composite safety endpoint was 14%, with a low incidence of all-cause mortality and stroke.
The international, multicenter, prospective, observational WIN-TAVI registry was designed to analyze the safety and performance of contemporary TAVR procedures among women with aortic stenosis. The results were presented at EuroPCR and published in JACC: Cardiovascular Interventions.
In total, 1,019 women from 20 European and North American centers were enrolled from January 2013 to December 2015. The mean patient age was 82 years, BMI 26 kg/m2, Society of Thoracic Surgeons score 8.3% and EuroSCORE 17.8%. Thirty percent of women had a history of chronic kidney disease, 26% diabetes, 23% prior PCI and 7.5% stroke. Also at baseline, 72% of women also reported a prior pregnancy, 17.5% osteoporosis, 10% frailty and osteoporosis, 9.3% breast cancer and 2.3% gynecological cancer.
All women had aortic stenosis and underwent TAVR with commercially available and approved TAVR devices and delivery systems. More than 90% of women underwent TAVR via transfemoral access. New-generation devices were used in 42% of cases, most commonly the Sapien 23-mm valve (Edwards Lifesciences) or CoreValve < 26-mm device (Medtronic). In one-third of women, a sheath size of 16F or smaller was used. Common indications for TAVR included high surgical risk, age older than 80 years and frailty. Most women had at least three high-risk indications for TAVR, according to the findings.
“With respect to procedural characteristics, this analysis represents current TAVR practice including mainly percutaneous transfemoral approach, low use of general anesthesia, 32% use of sheath sizes 16F and 42.1% use of new-generation devices,” Alaide Chieffo, MD, of San Raffaele Hospital in Milan, Italy, and colleagues wrote in JACC: Cardiovascular Interventions.
The primary endpoint was VARC-2 safety at 30 days. This endpoint comprised mortality, stroke, major vascular complications, life-threatening bleeding, acute kidney injury, coronary artery obstruction or repeat procedure for valve dysfunction. According to the results, the composite endpoint occurred in 14% of women at 30 days. Examined separately, the rate of stroke was 1.3%, all-cause mortality 3.4%, life-threatening bleeding 4.4% and major vascular complications 7.7%, acute kidney injury 1.3% and coronary artery obstruction 0.7%. BARC 3 or 5 bleeding occurred in 12% of patients.
When Chieffo and colleagues examined female-specific characteristics, the incidence of the primary safety endpoint was lower in women with a history of pregnancy (12.7% vs. 18.9%; P = .013). Compared with women who were never pregnant, those with a prior pregnancy had lower rates of stroke, combined stroke/mortality and acute kidney injury, but there was no difference in bleeding, vascular complications or 30-day mortality.
According to the researchers, “the effect of prior pregnancy will need to be confirmed at longer-term follow-up; however, this study remains novel for the evaluation of female sex-specific baseline characteristics in the context of TAVR.”
Age (OR = 1.04; 95% CI, 1-1.08), history of stroke (OR = 2.02; 95% CI, 1.07-3.8), ejection fraction < 30% (OR = 2.62; 95% CI, 1.07-6.4), device generation (OR = 0.59; 95% CI, 0.38-0.91) and prior pregnancy (adjusted OR = 0.57; 95% CI, 0.37-0.85) were independent predictors of the 30-day VARC-2 safety endpoint.
“Indeed, as the indication for TAVR continues to expand in intermediate-risk patients, the protective influence of new-generation TAVR devices is encouraging and may be due to the lower incidence of vascular and bleeding complications with smaller sheath sizes, more precise and accurate positioning with retrievable or partially retrievable devices, and lower paravalvular leak,” the researchers wrote. – by Katie Kalvaitis
Disclosure: This study was conducted without any external funding and was driven by the scientific interest and collaboration of the investigators. See the full study for the researchers’ other financial disclosures.
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