Transcatheter Aortic Valve Outcomes Better in Women Than Men at 12 Months
A new analysis is bolstering previous work showing that women are more likely than men to be alive 1 year after undergoing transcatheter aortic valve implantation, despite facing higher complications at the time of their procedures.
“Sex-specific risk in TAVR is the opposite of that in surgical aortic valve replacement, for which female sex has been shown to be independently associated with an adverse prognosis,” write Susheel Kodali, MD, of Columbia University Medical Center (New York, NY) and colleagues in an early online publication in the Annals of Internal Medicine.
According to the authors, the study is the largest analysis of sex-specific outcomes among TAVR treated patients thus far and should help clarify a signal seen in a number of smaller analyses that women fare better following TAVR than men.
Kodali et al examined outcomes among 2,559 high-risk or inoperable patients—of whom nearly half were women—treated at 25 different sites in the United States, Canada, and Germany. Immediately following TAVR, women were more likely to have bleeding or vascular complications, but less likely to have moderate or severe paravalvular leak. At 30 days, all-cause mortality was similar between women and men, but by 12 months, women were significantly more likely to be alive than men.
After adjusting for diabetes, COPD, STS-PROM score, major arrhythmia, renal disease, and liver disease, the improved survival among women remained significantly higher. No interaction was seen in an analysis that addressed access type (transfemoral or transapical).
Kodali and colleagues note that the findings are in keeping with a range of smaller studies, including at least 1 study using the CoreValve self-expanding device that showed a trend towards better survival in women. Possible explanations include a greater burden of comorbidities in men, smaller annulus sizes and greater ejection fractions in women pre-TAVR, and the lesser degree of paravalvular leak seen following procedures in women.
An accompanying editorial asks the obvious question: “Should these findings mean that more high-risk women with aortic stenosis should be recommended for TAVR instead of SAVR?” Nina Johnston, MD, and Christina Christersson, MD, both of Uppsala University in Sweden, write, “The simple answer is no; the available data are insufficient.”
However, they continue, the study does underscore the need to consider sex-based differences when studying any new intervention, given the implications for patient selection and evaluation of procedural risk.
In an email to TCTMD, Kodali argued that the findings do have “important implications for choosing a therapy.”
He pointed out that it is unlikely a trial of surgery versus TAVR will be undertaken in women only, although meta-analyses may ultimately provide some answers. In the meantime, he said, the “findings have important implications for choosing a therapy. An elderly female may be better suited for TAVR than SAVR, whereas the same may not be true for males.”
Ajay Kirtane, MD, also of Columbia University Medical Center and senior author on the study, agreed with Kodali. “These data . . . turn the conventional assessment of risk of aortic valve replacement on its head,” he told TCTMD in an email. In the past, a female patient is deemed to be higher risk for surgery than a male patient—something that is incorporated into the STS risk score. “These data suggest that if the patient is having a TAVR, then the reverse is actually true. This is a very simple but powerful message for the treating clinician,” he stressed.
As for whether device sizing or older versus current generation devices could explain some of the differences seen in the analysis, Kirtane pointed out that the consistency of the findings was seen across devices, with different mechanisms of action and different sizes. This suggests that better sizing cannot be the only driver of outcomes. That said, he noted, “the observation of less post-procedure aortic regurgitation in women is an important one [since] some of this may be mitigated by the use of newer generation devices,” which have been shown to reduce paravalvular leak.
Note: Kodali, Kirtane, and several other co-authors of the study are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.
1. Kodali S, Williams MR, Doshi D, et al. Sex-specific differences at presentation and outcomes among patients undergoing transcatheter aortic valve replacement: a cohort study. Ann Intern Med. 2016;Epub ahead of print.
2. Johnston N, Christersson C. Sex-specific research: a key component in improving prognosis after transcatheter aortic valve replacement [editorial]. Ann Intern Med. 2016;Epub ahead of print.
- The PARTNER trial was supported by grants from Edwards Lifesciences
- Kodali reports personal fees from Edwards Lifesciences, nonfinancial support from Medtronic, and service on the Scientific Advisory Board for Thubrikar Aortic Valve outside the submitted work.
- Dr. Kirtane reports grants to Columbia University/Cardiovascular Research Foundation from Edwards Lifesciences during the conduct of the study and institutional research grant support to Columbia University from Medtronic, Boston Scientific, Abiomed, Abbott Vascular, Vascular Dynamics, St. Jude Medical, Eli Lilly, and GlaxoSmithKline.