"Being female has a positive ('protective') impact on post-TAVI permanent pacemaker implantation, with a risk reduction of 10%, independent of age or cardiac function," said Dr. Justine Ravaux of Maastricht University Medical Center Cardiology/Cardiac Surgery Research Group, in the Netherlands.
"We also identified a possible increasing risk of post-TAVI permanent pacemaker implantation for female subjects when using a balloon-expandable valve," she told Reuters Health by email. "However, as this study is a meta-analysis of the published literature, (the findings) should be considered with caution. A patient-level analysis should help the clinician to decide on the use of balloon-expandable valve in a specific sex category."
"Interestingly, as a collateral finding, this study identified a reduction in women undergoing TAVI during the last 10 years," she added. "We still don't have any explanation for such a finding. However, as the long-term outcomes after TAVI seem to be favorable to women," further study is needed.
As reported in the Journal of the American Heart Association, Dr. Ravaux and colleagues analyzed data on more than 70,000 patients, about half of them women, participating in 46 studies. The primary endpoint was 30-day or in-hospital permanent pacemaker implantation after TAVI.
As Dr. Ravaux noted, the proportion of women undergoing TAVI dropped significantly over time. The cumulative overall rate of pacemaker implantation was 15.6%; the cumulative rate for women was lower than for men, at 14.9% versus 16.6%.
The overall risk for a post-TAVI pacemaker was lower in women (odds ratio, 0.90; P=0.0022); however, as Dr. Ravaux also noted, balloon-expandable TAVI significantly decreased the advantage for women, which then approached the same rate as for men.
Neither age nor ventricular function was associated with pacemaker implantation for either sex.
Dr. Hasan Jilaihawi, director of research for the Heart Valve Center at NYU Langone Health in New York City, disagrees with the findings.
"Many of the included studies are from several years ago and this field has changed dramatically in the past few years, most importantly with regard to positioning valves more precisely in relation to the location of the conduction system, which varies from patient to patient," he told Reuters Health by email.
"This precision medicine approach has dramatically reduced the rate of pacemaker after TAVR to less than 5% in our experience, regardless of valve type and gender," he said.
"Much of the gender-related risk for self-expanding TAVR is likely to have been driven by the largest size Medtronic CoreValve before it was repositionable," he noted. "The largest size was almost exclusively used to treat males and especially difficult to reposition."
"This is an important confounder," he noted, "due to the lack of patient-level data with regard to EKG, CT or procedural aspects that are the most important determinants of pacemaker risk."
Like Dr. Ravaux, he concluded, "With any technology or therapy that is rapidly evolving, meta-analyses should be interpreted with caution."
SOURCE: https://bit.ly/3uwCUna Journal of the American Heart Association, online March 27, 2021.
By Marilynn Larkin
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