Low Incidence of Early Mortality in First All-Female Transcatheter Aortic Valve Replacement Study

In the first ever all-female transcatheter aortic valve replacement (TAVR) registry, women experienced a low incidence of early mortality and stroke.

Findings were announced at the EuroPCR meeting in Paris this month, and simultaneously published in JACC: Cardiovascular Interventions.

As the study authors pointed out, female sex itself is an independent predictor of survival in older patients undergoing conventional surgical aortic valve replacement (SAVR). Frailty, osteoporosis, history of pregnancy, and age of menopause are also important when considering a female patient for TAVR.

WIN-TAVI (Women in Transcatheter Aortic Valve Implantation) is an international, prospective, observational registry of women undergoing TAVR at European and North American centers. To be included in the study, women had to have severe aortic stenosis (AS), symptoms of angina, congestive heart failure, New York Heart Association (NYHA) functional class ≥ II, or syncope.

Among the female sex-specific baseline characteristics, 72.4% patients had a history of pregnancy, 17.5% had a history of osteoporosis, and 10.1% were noted to have frailty and osteoporosis.

The primary end point was VARC 2 (Valve Academic Research Consortium) early safety end point at 30 days, which was a composite of all-cause mortality, all stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury (AKI), coronary artery obstruction, or repeat procedure for valve-related dysfunction.

In addition, researchers measured individual safety end points that included all-cause mortality, cardiovascular mortality, all stroke, myocardial infarction, bleeding (VARC 2 life-threatening or disabling bleeding, major bleeding, and BARC [Bleeding Academic Research Consortium] bleeding 3 or 5), stage 2 or 3 AKI, and vascular complications.

A total of 1019 women (mean age: 82.5 ± 6.3 years) were enrolled in WIN-TAVI between January 2013 and December 2015. In more than 90% of cases, TAVR was performed via transfemoral access, and new-generation devices were used in 42.1%. The SAPIEN 23mm (Edward Lifesciences; Irvine, CA) or CoreValve ≤26mm (Medtronic; Dublin, Ireland) was implanted in more than two-thirds of the cases.

The 30-day VARC 2 composite end point occurred in 14.0% of patients, with 3.4% all-cause mortality (3.3% being cardiac deaths), 1.3% of patients experienced stroke, 7.7% experienced major vascular complications, 4.4% experienced VARC life threatening bleeding, and 12% experienced BARC 3 or 5 bleeding. In addition, coronary artery obstruction occurred in 0.7% of patients, TAV-in-TAV in 1.7%, and surgical conversion in 0.7%. AKI at stage 2 or 3 occurred in 1.3% of patients. After TAVR, 21.9% of patients experienced arrhythmia or conduction disturbance, and new permanent pacemaker implantation was performed in 12.1% of patients. Aortic incompetence ≥grade 2 occurred in 14.1% of patients and ≥grade 3 in 1.9%.

Age, prior stroke, ejection fraction <30%, device generation, and history of pregnancy were independent predictors of the primary end point. Univariable analysis demonstrated that patients who had prior stroke, higher Society of Thoracic Surgeons score, and left ventricular ejection fraction <30% had higher occurrence of the primary safety end point.

“The observed rate of vascular and bleeding complications in the current study was lower than prior studies, which have reported an incidence upwards of 7-10%,” researchers noted. They acknowledged that the patient population in this study was of a lower-risk profile as well as the use of newer-generation devices and the skill of the TAVR operators and facilities—all of which may have contributed to the lower bleeding complication rates.

Researchers encouraged future studies to compare TAVR vs SAVR in “intermediate-risk women with severe aortic stenosis” in order to determine optimal treatment strategies.

Reference

Chieffo A, Petronio AS, Mehilli J, et al; on behalf of WIN TAVI Investigators. Acuate and 30-day outcomes in women after TAVR: results from the first women in transcatheter aortic valve implantation (WIN-TAVI) real world registry. JACC Cardiovasc Interv. 2016. doi: 10.1016/j.jcin.2016.05.015.