PARIS, FRANCE — Having a history of pregnancy also decades earlier was protective versus complications in women at intermediate to higher risk undergoing transcatheter aortic-valve alternative (TAVR), according to outcomes from the initial Women in Transcatheter Aortic Valve Implantation (WIN-TAVI) real-globe registry study[1].
History of pregnancy was associated along with a lesser price of the 30-day primary safety end point of all-induce mortality, stroke, severe vascular complication, life-threatening bleeding, phase 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 once I checked out this result, I believed this was a selection bias,” study author Dr Alaide Chieffo (San Raffaele Scientific Institute, Milan, Italy) told heartwire from Medscape.
After all, the standard age of the women in the study was 82.5 years, and women from that generation frequently became pregnant in their twenties. “So why after 60 years there is an impact is not something that you could have actually predicted,” she added.
In all, 72.4% of the 1019 women in the study had a history of pregnancy, defined just 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: Cardio Interventions.
Notably, just 31 women reported having a pregnancy-related complication, either gestational diabetes or hypertension. As a result, the investigators could not identify the motivate of preeclampsia, a condition increasingly identified as a risk factor for subsequent inadequate cardiac health.
“once you do a study you must collect female-individual characteristics, due to the fact that every one of these thousands and thousands and thousands of patients are treated [and] we don’t have actually the numbers,” Chieffo said to heartwire . Obtaining that data has actually been challenging provided the disinterest among predominantly male principal investigators also as drug and device makers, a lack of awareness concerning the reason for sex-individual 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 devoid of outside support, enrolled 1019 women across twenty mostly European centers in between January 2013 and January 2015. the majority of 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 crucial requirement for TAVR in 89%, however 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 focus were likewise factors, Chieffo said.
The procedural characteristics reflect contemporary practice, along with a sheath dimension of <18 F in a minimum of 90% and new-generation machines including Edward Sapien XT, Medtronic CoreValve, Lotus, and Symetis Acurate Neo used in 42.1%.
At 30 days, the primary safety end point ensued in 14.4% of patients. Rates were reasonable for the secondary end points of all-induce mortality (3.9%), stroke (1.3%), all-induce mortality or stroke (4.9%), severe 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 sized femoral artery, annuli, and valve dimensions might explain the various outcomes reported for women and men in Various other studies and asked whether the investigators strategy to perform a propensity-matched analysis in a comparable population of men.
Chieffo agreed that this is a various population, however said such an analysis is unlikely. “The [focus] of the study . . . was the female characteristics, due to the fact that no Various other studies have actually collected just what is characteristic of the female population: history of osteoporosis, history of menopause, a complication throughout pregnancy. The initial try is to observe along with longer follow-up whether just what we discovered at 30 days is confirmed.”
Chieffo reported lecture fees and institutional research grant assist 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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