Gender Disparities in Management and Outcomes Following Transcatheter Aortic Valve Implantation With Newer Generation Transcatheter Valves

Gracia, Ely; Callahan, Susan; Bilfinger, Thomas V.; Tannous, Henry; Pyo, Robert; Kort, Smadar; Skopicki, Hal A.; Weinstein, Jonathan; Patel, Neal; Montellese, Daniel; Korlipara, Giridhar; Khan, Shamim; Chikwe, Joanna; Parikh, Puja B.

doi:10.1016/j.amjcard.2019.01.048

Cited by 19 publications

(27 citation statements)

References 21 publications

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“…This finding is not surprising given the differing anatomy between sexes. Women are known to have smaller peripheral vessels, which lends itself to increased risk of peri-procedural vascular injury [42][43][44]. We also found women were significantly less likely to experience a major bleed or acute kidney injury following TAVI while men experienced similar rates of bleeding and acute kidney injury regardless of the type of intervention [40].…”

Section: Summary Of Main Resultssupporting

confidence: 51%

Transcatheter Versus Surgical Aortic Valve Replacement: An Updated Systematic Review and Meta-Analysis With a Focus on Outcomes by Sex

Dagan

Yeung

Stehli

et al. 2021

Heart, Lung and Circulation

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Background and Aims Women at increased surgical risk have been shown to have better outcomes with transcatheter aortic valve implantation (TAVI) as compared to surgical valve replacement (SAVR). With the scope of TAVI moving into low-surgical risk patients, we aimed to update the current literature to include the new low-risk randomised controlled trial (RCT) data in investigating outcomes by sex. Methods We systematically searched MEDLINE (Ovid), PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and reference lists for relevant RCTs comparing TAVI to SAVR published prior to 4 May 2020. Data extraction was performed by two independent authors and included trial design details, baseline characteristics and outcome data stratified by sex. Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool. Quantitative synthesis of pooled data was performed using Mantel-Haenszel fixed or random effects model. Q-statistic and the I 2 test were used for assessment of heterogeneity. Results Our search yielded eight RCTs included in the final quantitative synthesis. The overall pooled cohort was 8,040, of whom 41.4% were female. Women had significantly lower rates of one-year all-cause mortality (12.2% vs 17.7%, pooled OR 0.59, 95% CI 0.40-0.86) and one-year composite endpoint (9.7% vs 12.4%, pooled OR 0.73, 95% CI 0.58-0.92) with TAVI as compared to SAVR. The selective mortality benefit with TAVI over SAVR in women did not persist to 5 years (pooled HR 1.01, 95% CI 0.87-1.17). At 30 days, women demonstrated lower rates of major bleeding and acute kidney injury following TAVI compared to SAVR. For men, these outcomes were similar regardless of type of intervention. Both sexes were at increased risk of major vascular complications with TAVI as compared to SAVR, however women demonstrated nearly double the odds of major vascular complication with TAVI compared to men. Conclusion Our updated meta-analysis demonstrates that at one-year women undergoing TAVI have significantly lower mortality and better safety outcomes compared to those undergoing SAVR. These benefits are not seen in men. In the new low-risk era, these results are ever more important for guiding appropriate patient selection.

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Section: Summary Of Main Resultssupporting

confidence: 51%

Transcatheter Versus Surgical Aortic Valve Replacement: An Updated Systematic Review and Meta-Analysis With a Focus on Outcomes by Sex

Dagan

Yeung

Stehli

et al. 2021

Heart, Lung and Circulation

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“…In one study (15), the outcome data for Evolut R and Sapien 3 valves were not presented separately. Another study (16) examined gender-based differences in outcomes, in a cohort of Evolut R and Sapien 3 TAVI patients without any comparison between the 2 valves. A total of 5 studies (8,17–20) met the inclusion criteria and were included in the systematic review and meta-analysis.…”

Section: Resultsmentioning

confidence: 99%

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

He¹,

Lang

2019

Exp Ther Med

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The aim of this study was to systematically search literature and conduct a meta-analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66–1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83–3.54; P=0.14; I2=0%). Both mean [random; mean difference (MD) = −3.96; 95% CI, −4.61 to −3.31; P<0.00001, I2=0%] and peak (random; MD = −6.85; 95% CI, −8.22 to −5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30-day mortality (OR, 1.32; 95% CI, 0.45–3.87; P=0.62; I2=0%) or 30-day stroke outcomes (OR, 0.76; 95% CI, 0.32–1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short-term complications. The differences between the 2 devices for post-operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi-center randomized controlled trial to provide stronger evidence on this subject.

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“…Ayrıca kadın hastaların femoral arter çapının nispeten daha küçük olması TAVI sistemine bağlı olarak daha fazla femoral arter yaralanması riskini ve işlem sonrası kanama komplikasyonunu beraberinde getirmektedir 16,17 . Uzun dönemde ise atrial fibrilasyon sıklığının ve koroner arter hastalığının kadınlarda daha az olması nedeniyle kanama komplikasyonunu erkek hastalarda daha sık izlemekteyiz 18 .…”

Section: Discussionunclassified

“…Bununla birlikte balon ile genişleyebilen kapakların kendiliğinden genişleyebilen kapaklara göre daha az atriyoventriküler bloğa neden olması nedeniyle kadın hastalarda daha az pil ihtiyacı görülmektedir. Kalıcı pace makerin sol ventrikülde elektriksel ve mekaniksel dissenkroni yaratarak 1 yıllık takipte tüm nedenlere bağlı ölüm ve kalp yetmezliği nedeniyle hastaneye yatış sıklığındaki artış ve pile bağlı komplikasyon sıklığı kadın hastalarda azalmakta [17][18][19][20] .…”

Section: Discussionunclassified

Transkateter Aortik Kapak Replasmanında Kısa Süreli Takipte Cinsiyet Farkı

Urgun¹,

Traş²,

Kurt³

et al. 2020

City Med J

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Introduction: The prognostic value sex difference demonstrated in cardiovascular diseases. In present study, we evaluated the prognostic value of sex difference in patients who underwent transcatheter aortic valve replacement (TAVI). Material and Methods: Totally, 130 patients who underwent TAVI between January 2016 and December 2018 included retrospectively. Median follow-up time was 324 (IQR 226) days. Demographic characteristic of patients recorded from hospital record system and patients’ fields. Primary outcome was all cause mortality during follow-up. Results: Mean age of study population was 77.1 ± 7.8 years and female gender was significantly older than male gender. There was no significant difference between groups in term of demographic and laboratory parameters except smoker rate and mean haemoglobin level. During follow-up totally 34 (%26.2) patients were died (male 34.5%, female 20.0%; p= 0.062) and there was no significant difference between groups. Conclusion: In our single-center retrospective study, we showed that there was no significant difference in gender difference in all-cause mortality during short-term follow-up after TAVI.

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Gender Disparities in Management and Outcomes Following Transcatheter Aortic Valve Implantation With Newer Generation Transcatheter Valves

Cited by 19 publications

References 21 publications

Transcatheter Versus Surgical Aortic Valve Replacement: An Updated Systematic Review and Meta-Analysis With a Focus on Outcomes by Sex

Transcatheter Versus Surgical Aortic Valve Replacement: An Updated Systematic Review and Meta-Analysis With a Focus on Outcomes by Sex

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

Transkateter Aortik Kapak Replasmanında Kısa Süreli Takipte Cinsiyet Farkı

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