Patrice Wendling

May 18, 2016

PARIS, FRANCE — Having a history of pregnancy even decades earlier was protective against complications in women at intermediate to high risk undergoing transcatheter aortic-valve replacement (TAVR), according to results from the first Women in Transcatheter Aortic Valve Implantation (WIN-TAVI) real-world registry study[1].

History of pregnancy was associated with a lower rate of the 30-day primary safety end point of all-cause mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction requiring intervention, or repeat procedure for valve-related dysfunction (adjusted odds ratio [OR] 0.57, P=0.007).

"Initially when I saw this result, I thought this was a selection bias," study author Dr Alaide Chieffo (San Raffaele Scientific Institute, Milan, Italy) told heartwire from Medscape.

After all, the average age of the women in the study was 82.5 years, and women from that generation typically became pregnant in their twenties. "So why after 60 years there is an impact is not something that you could have predicted," she added.

In all, 72.4% of the 1019 women in the study had a history of pregnancy, defined simply as 'yes' or 'no' and not whether it ended in a live birth, according to the data reported at EuroPCR 2016 and simultaneously published online in JACC: Cardiovascular Interventions.

Notably, only 31 women reported having a pregnancy-related complication, either gestational diabetes or hypertension. As a result, the investigators could not identify the influence of preeclampsia, a condition increasingly identified as a risk factor for subsequent poor cardiac health.

"When you do a study you should collect female-specific characteristics, because all these thousands and thousands and thousands of patients are treated [and] we don't have the numbers," Chieffo said to heartwire . Getting that data has been challenging given the disinterest among predominantly male principal investigators as well as drug and device makers, a lack of awareness regarding the need for sex-specific data, and a sometimes-dismissive attitude reflected among some attendees by the laughter that greeted her findings.

All-Female Observational Registry

The current study, conducted without outside support, enrolled 1019 women across 20 mostly European centers between January 2013 and January 2015. Most patients were white (95.8%), their mean ejection fraction was 55.7%, 9.6% had a prior MI, and 19.6% had atrial fibrillation on baseline electrocardiography.

High surgical risk was listed by the investigator as the key reason for TAVR in 89%, but this was not reflected in the mean EuroScore of 17.8 or mean STS score of 8.3, suggesting that comorbidities such as age and frailty or choice of the center were also factors, Chieffo said.

The procedural characteristics reflect contemporary practice, with a sheath size of <18 F in at least 90% and new-generation devices including Edward Sapien XT, Medtronic CoreValve, Lotus, and Symetis Acurate Neo used in 42.1%.

At 30 days, the primary safety end point occurred in 14.4% of patients. Rates were low for the secondary end points of all-cause mortality (3.9%), stroke (1.3%), all-cause mortality or stroke (4.9%), major vascular complications (7.9%), and life-threatening bleeding (4.4%).

Other independent predictors of the primary end point were age, prior stroke, ejection fraction, and TAVR-device generation.

Session cochair Dr Alain Cribier (Charles Nicolle Hospital, University of Rouen, France) said the smaller femoral artery, annuli, and valve sizes may explain the different results reported for women and men in other studies and asked whether the investigators plan to perform a propensity-matched analysis in a similar population of men.

Chieffo agreed that this is a different population, but said such an analysis is unlikely. "The [focus] of the study . . . was the female characteristics, because no other studies have collected what is characteristic of the female population: history of osteoporosis, history of menopause, a complication during pregnancy. The first aim is to see with longer follow-up whether what we found at 30 days is confirmed."

Chieffo reported lecture fees and institutional research grant support from Edwards Lifesciences and Abbott Vascular and lecture fees from Lilly/Daiichi Sankyo, Terumo, and Bristol-Myers Squibb. Disclosures for the coauthors are listed in the article.

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