Transcatheter Aortic Valve Replacement

Sex-Related Differences in Early- and Long-Term Mortality After Transcatheter and Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Puja B. Parikh, MD, MPH1; Ting-Yu Wang, BS1; Navneet Sharma, MD1; Smadar Kort, MD1; Hal A. Skopicki, MD, PhD1; Luis Gruberg, MD1; Allen Jeremias, MD1; Robert Pyo, MD1; Joanna Chikwe, MD2,3; Javed Butler, MD1

Puja B. Parikh, MD, MPH1; Ting-Yu Wang, BS1; Navneet Sharma, MD1; Smadar Kort, MD1; Hal A. Skopicki, MD, PhD1; Luis Gruberg, MD1; Allen Jeremias, MD1; Robert Pyo, MD1; Joanna Chikwe, MD2,3; Javed Butler, MD1

Abstract: Background. Observational data suggest that early- and long-term outcomes of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differ significantly between men and women, but have demonstrated conflicting results. This study sought to examine early- and long-term mortality with TAVR and SAVR in women versus men. Methods. Electronic search was performed until February 2018 for studies reporting sex-specific mortality following TAVR or isolated SAVR. Data were pooled using random-effects models. Outcomes included rates of early mortality (in hospital or 30 days) and long term (1 year or longer). Results. With 35 studies, a total of 80,928 patients were included in our systematic review and meta-analysis, including 40,861 men and 40,067 women. Pooled analyses suggested considerable sex-related differences in long-term mortality following TAVR and SAVR. Following SAVR, women had higher long-term mortality (odds ratio [OR], 1.35; 95% confidence interval [CI], 1.16-1.56; P<.001) and a trend toward higher early mortality (OR, 1.69; 95% CI, 0.97-2.97; P=.07) compared to men. Following TAVR, women had lower long-term mortality (OR, 0.78; 95% CI, 0.71-0.86; P<.001) and no difference in early mortality (OR, 1.09; 95% CI, 0.96-1.23; P=.17) compared to men. Conclusions. In this systematic review and meta-analysis, women had higher long-term mortality and a trend toward higher early mortality compared to men following SAVR. Following TAVR, women had lower long-term mortality and no difference in early mortality compared with men. 

J INVASIVE CARDIOL 2020 March 20 (Epub Ahead of Print).

Key words: long-term mortality, surgical risk


Symptomatic aortic stenosis (AS) is a common valvular heart disease that leads to a high rate of death if left untreated.1 Transcatheter aortic valve replacement (TAVR) is the standard of care to treat patients with AS who are at high or prohibitive risk for surgical aortic valve replacement (SAVR).2,3 More recently, low and intermediate surgical risk patients have been undergoing TAVR as well.4,5 Several studies have reported sex-specific incidence of morbidity and mortality after both TAVR and SAVR, but their results have been inconsistent. Consequently, the association between sex and early-, intermediate-, and late-term mortality in adults undergoing TAVR and SAVR remains unclear. Given the equipoise surrounding this issue, we conducted an updated and comprehensive systematic review and meta-analysis of all published studies to specifically investigate the difference in early, intermediate, and late mortality in men and women undergoing TAVR or SAVR.

Methods

Data searches. We report this systematic review in accordance with the Preferred Reporting of Items for Systematic reviews and Meta-Analyses (PRISMA) statement. We systematically searched Medline and Cochrane Database of Systematic Reviews from inception to February 19, 2018 for randomized trials and observational studies examining the relationship between sex and mortality in adults following TAVR or SAVR. The following search strategy was used: (aortic valve replacement or aortic valve intervention or aortic valve surgery) and (male or female or men or women or sex or gender) and (death or mortality or survival or outcomes). In addition, reference lists of pertinent articles were screened for potentially relevant citations missed by electronic searches. All study designs (prospective observational, retrospective, randomized controlled trials, and registries) were included. 

Study selection. Studies were initially screened at the level of title and abstract, and then full-length reports were retrieved for detailed evaluation. Two authors (PBP, TYW) independently selected articles according to prespecified inclusion and exclusion criteria. Any discrepancy was resolved by consensus of the authors. Articles were included if they reported the number, incidence, or summary estimates for all-cause death for men and women separately undergoing TAVR or isolated SAVR. We restricted our analysis to published data. Abstracts and reviews were excluded, as were articles published in languages other than English. 

Data extraction. Independently and in duplicate, two authors (PBP, TYW) extracted data. A table was designed to record data of eligible studies on the year of publication, study period, study type, risk score, number of men and women, access type (for TAVR studies), prosthetic valve type, follow-up duration, and mortality data. Mortality included all-cause mortality at early term (in hospital or 30 day) or long term (1 year or longer).

Statistical analysis. Because individual patient-level data from each study were not available, a meta-analysis of summary statistics from individual studies was performed using Comprehensive Meta-Analysis software, version 3 (Biostat, Inc). The association between sex and mortality was presented as an odds ratio (OR) with 95% confidence interval (CI) by applying the random-effects model. 

The presence of statistically significant heterogeneity was assessed by the Q statistic (significant at P < .10), and the extent of any observed heterogeneity was determined by I2 (ranging from 0% to 100%). When between-study heterogeneity existed, we performed random-effects meta-analysis. Since the absence of statistical heterogeneity does not guarantee clinical homogeneity, summary ORs for all endpoints were calculated using a random-effects model from the ORs and 95% CIs for mortality in each study. The random-effects model provides a more conservative summary estimate because it incorporates both within-trial and between-trial variance. A P-value  < .05 was considered statistically significant, and all tests were 2-sided unless otherwise indicated.  To qualitatively assess publication bias, a funnel plot of the logarithm of effect size vs the standard error for each trial was generated. The Egger weighted linear regression test was used to examine the quantitative association between mean effect estimate and its variance.

Results

Literature search and study selection. The process of study selection is illustrated in Figure 1. There were 8299 citations after removing duplicates. A total of 8177 citations were excluded as the titles and/or abstracts were not relevant to the proposed study. The remaining 122 articles were examined in greater detail for relevance. Fourteen of these citations were excluded due to absence of data on (or summary-estimates for) early- or long-term sex-specific mortality. Another 25 citations were excluded as these were either review articles, meta-analyses, or editorials. Forty-seven citations were excluded due to inappropriate study populations.  A total of 35 articles were eligible for systematic review and meta-analysis, with 28 studies on TAVR6-33 and 7 studies on SAVR.34-40

Study, patient, and procedural characteristics. The characteristics of the included studies are presented in Table 1 and Table 2. The 28 TAVR studies6-33 and 7 SAVR studies34-40­ included 80,928 adults (40,861 men and 40,067 women) for the comparison of sex-related differences in mortality after TAVR or SAVR. 

Association between sex and mortality in TAVR. The association between sex and early- and long-term mortality following TAVR was quantitatively assessed in 266-15,17-27,29-33 and 19 studies,7,9-18,20-22,24,26,27,29,30,32,33 respectively. For studies in which 30-day mortality was not available,11,15,29,31,34,35 in-hospital mortality was utilized instead.The pooled results demonstrated that following TAVR, men had higher long-term mortality (OR, 1.28; 95% CI, 1.16-1.40; P<.001) and no difference in early mortality (OR, 0.92; 95% CI, 0.81-1.04; P=.17) compared with women (Figures 2A and 2B). 

Association between sex and mortality in SAVR. The association between sex and early- and long-term mortality following SAVR was quantitatively assessed in 6 studies34-36,38-40 and 4 studies,34,36-38 respectively. The pooled results demonstrated that following SAVR, men had lower long-term mortality (OR, 0.74; 95% CI, 0.64-0.86; P<.001) and a trend toward lower early mortality (OR, 0.59; 95% CI, 0.34-1.03; P=.07) compared with women (Figures 3A and 3B). 

The funnel plots for each analysis (Figures 4A and 4B) were symmetric, suggestive of a lack of publication bias. 

Discussion

The principal findings of this systematic review and meta-analysis of all published randomized and observational studies examining the relationship between sex and mortality in adults following TAVR or SAVR are: (1) men had lower long-term mortality following SAVR compared with women; (2) men had higher long-term mortality following TAVR compared with women; and (3) there was no difference in early mortality following SAVR or TAVR in men and women. These findings are unique in that this is the first meta-analysis to our knowledge to address sex-specific disparities in early- and long-term mortality with SAVR. It is also one of the largest studies to date addressing early- and long-term mortality in women vs men undergoing TAVR.

Sex-related differences in left ventricular adaptation to AS exist, with ventricular dysfunction being more common in men.41 Furthermore, the increased left ventricular wall thickness and smaller left ventricular systolic cavities with narrow outflow tracts seen in women have been associated with increased early mortality and morbidity in women following aortic valve replacement.42-45 Sex-specific pathophysiologic responses to pressure overload caused by AS exists, as it has been reported that women show a tendency toward greater ventricular hypertrophy despite equal transvalvular gradients41 and female sex has been independently associated with recovery of left ventricular ejection fraction following aortic valve replacement.45 Women also are more likely to receive smaller prosthetic valves, more frequently undergo aortic annular enlargement procedures, have greater technical difficulty associated with smaller anatomy, and have more bleeding complications related to cardiopulmonary bypass (ie, transfusion requirements).46,47

More recent data have emerged demonstrating improved outcomes in women following TAVR.29,39,48-50 Using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, Chandrasekhar et al demonstrated no difference between in-hospital mortality in men and women following TAVR but significantly lower 1-year mortality in women vs men,29 results that were confirmed in a recent meta-analysis by Saad et al.72 A patient-level meta-analysis by O’Connor et al noted similar 30-day mortality between men and women following TAVR but better long-term survival in women.48 Subgroup analyses from the Placement of Aortic Transcatheter Valves (PARTNER) trial and the CoreValve US Pivotal trial also demonstrated improved 1-year outcomes in women following TAVR compared with SAVR.39,49 

Poor outcomes associated with prosthesis-patient mismatch (PPM) for SAVR have been well described in prior studies.51-53 It has been suggested that women experience PPM more frequently than men due to smaller valve sizes in women.54 While TAVR has been shown to have lower PPM rates than SAVR,52 reports of poor outcomes with PPM after balloon-expandable and self-expanding TAVR52,55 suggest that avoiding PPM may be an important variable in preprocedural planning.56 Many studies have investigated the impact of sex on postimplantation PPM, and although there was a trend toward higher rates of PPM among women in one study,57 most studies have shown that women do not appear to be at increased risk of this complication despite the frequent need for smaller valves.58-60 TAVR may seem to be a preferred modality in women who are surgical candidates but have smaller annular dimensions, given the lower incidence of postprocedural PPM compared with surgery.61 Future studies directly comparing TAVR vs SAVR specifically in this cohort with small aortic annuli to assess the possible impact of PPM on long-term clinical outcomes are warranted.

Study limitations. The current study is the largest analysis providing sex-specific outcomes of early- and late-term mortality in men and women following TAVR or SAVR. Our meta-analysis, however, should be interpreted within the context of several limitations. First, the included studies are primarily observational and so unmeasurable confounders may have affected the results. Second, there was significant heterogeneity between studies with respect to the study population (ie, surgical risk), TAVR access, and TAVR or SAVR valve type. Third, although great care was taken in selecting studies, the possibility of duplicated data synthesis as a result of their overlap in the patients enrolled cannot be completely ruled out. Finally, the lack of patient-level data precluded a more robust analysis.

Conclusion

In this systematic review and meta-analysis, women had higher long-term mortality following SAVR and lower long-term mortality following TAVR when compared with men. There was no significant difference in short-term outcomes following TAVR or SAVR. This is the largest study to date of sex-specific differences in early- and long-term mortality in men and women undergoing TAVR and the only study to date examining sex disparities in early- and long-term mortality in patients undergoing SAVR. 


From the 1Division of Cardiovascular Medicine, Department of Medicine, State University of New York at Stony Brook, Stony Brook, New York; 2Division of Cardio- thoracic Surgery, State University of New York at Stony Brook, Stony Brook, New York; 3Division of Cardiothoracic Surgery, Icahn School of Medicine at Mount Sinai, New York, New York.

Disclosure: The authors have completed and returned the ICMJE Form for Dis- closure of Potential Conflicts of Interest. Dr Parikh reports consultant fees from Medtronic; scientific advisory board for AstraZeneca. Dr Jeremias reports con- sultant fees from Philips, Abbott, Boston Scientific, and Acist, Dr Butler reports consultant fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Mayers Squib, CVRx, G3 Pharmaceutical, Janssen, Luitpold, Medtronic, Merck, Novartis, and Vifor. Dr Chikwe reports honoraria and fees to her institution from Edwards Lifesciences and Medtronic for speaker and consulting activities. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript submitted September 15, 2019, provisional acceptance given September 24, 2019, final version accepted October 2, 2019.

Address for correspondence: Puja B. Parikh, MD, MPH, FACC, FAHA, FSCAI, Medical Director, Transcatheter Aortic Valve Replacement Program, Assistant Professor, Department of Medicine, Stony Brook University Medical Center, Health Sciences Center T16-080, Stony Brook, NY 11794. Email: puja.parikh@ stonybrookmedicine.edu

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