Transcatheter Aortic Valve Replacement

Transcatheter Aortic Valve Replacement

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 68, NO. 25, 2016 ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 0735-1097/$36.00 ...

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

VOL. 68, NO. 25, 2016

ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

ISSN 0735-1097/$36.00

PUBLISHED BY ELSEVIER

http://dx.doi.org/10.1016/j.jacc.2016.10.042

EDITORIAL COMMENT

Transcatheter Aortic Valve Replacement Only One of the Advantages of Being Female* Molly Szerlip, MD

F

emale sex has been an independent predictor

respectively). Female patients were in general older

of worse outcomes after surgical aortic valve

and had higher STS scores but were less likely to have

replacement (SAVR). Over the past decade,

pre-existing

coronary

artery

disease,

previous

transcatheter aortic valve replacement (TAVR) has

myocardial revascularization, atrial fibrillation, dia-

become the standard of care for treatment of severe

betes, and lung disease. However, they were more

symptomatic aortic stenosis in high-risk and inoper-

likely to have a lower glomerular filtration rate,

able patients. In contradistinction to the SAVR data,

moderate to severe mitral regurgitation, and porce-

TAVR outcomes data from the initial pivotal random-

lain aorta. Female patients were also more likely to

ized trials and sponsor’s post-approval registries have

be treated by using a nontransfemoral access (45.0%

shown

patients

vs. 35.0%) and were more likely to have a surgical

compared with male patients. This benefit occurs

cutdown (36.8% vs. 32.4%). During the TAVR pro-

despite higher periprocedural vascular and bleeding

cedure, female patients were more likely to be con-

complication rates in female patients. The exact rea-

verted to open surgery for complications such as

sons as to why female sex in TAVR confers a survival

aortic dissection, annular rupture, and coronary oc-

benefit compared with male sex, especially when it is

clusion. As expected, they also had a higher inci-

diametrically the opposite of SAVR, have yet to be

dence of vascular complications. However, none of

determined (1–4).

these increased risk factors or periprocedural com-

a

survival

benefit

for

female

SEE PAGE 2733

plications translated into an increase in mortality for women at discharge or at 1 year. In fact, at 1 year,

In this issue of the Journal, Chandrasekhar et al.

women demonstrated higher survival (78.7% vs.

(5) report the largest series to date of patients un-

75.5%; hazard ratio: 0.73; 95% confidence interval:

dergoing TAVR and analyze the outcomes according

0.63 to 0.85; p < 0.001). These outcomes data confirm

to sex. This study compared in-hospital and 1-year

the results of the previous randomized trials and are

outcomes post-TAVR between male and female pa-

indicative that the trial results are generalizable to

tients from the Society of Thoracic Surgeons/Amer-

the treated population after commercial approval;

ican College of Cardiology (STS/ACC) Transcatheter

that being said, it remains a subject of speculation as

Valve Therapy (TVT) Registry. This real-world expe-

to why there is a survival difference benefiting fe-

rience reflects the clinical trial experience. The study

male patients undergoing TAVR, especially because

examined >23,000 patients receiving TAVR between

this outcome is exactly the opposite of SAVR out-

2011 and 2014 with an almost equal proportion

comes according to sex.

of female and male patients (49.9% and 51.1%,

Despite female patients being older than their male counterparts and deemed to be more debilitated, deconditioned, and frail, they had fewer comorbid conditions than male patients, which could

*Editorials published in the Journal of the American College of Cardiology reflect the views of the authors and do not necessarily represent the views of JACC or the American College of Cardiology. From The Heart Hospital Baylor Plano, Plano, Texas. Dr. Szerlip has

lead to mortality (5). These comorbidities included less coronary artery disease, resulting in less revascularization with percutaneous coronary interven-

served as a speaker and proctor for Edwards Lifesciences; as a consultant

tion and coronary artery bypass graft, less peripheral

and speaker for Medtronic; and as a speaker for Abbott Vascular.

vascular disease, atrial fibrillation, and chronic

2746

Szerlip

JACC VOL. 68, NO. 25, 2016

Advantages of Being Female

DECEMBER 27, 2016:2745–6

obstructive pulmonary disease. This lower incidence

left ventricular mass regression after aortic valve

of risk factors could potentially explain the lower

replacement (7).

mortality. Although women had less peripheral

One should, however, interpret the results of this

vascular disease overall, they had more vascular

study by Chandrasekhar et al. (5) with caution. The

complications periprocedurally, likely due to smaller

findings of this study are only applicable to the

access blood vessels with relatively large delivery

population that was studied and should not neces-

sheaths. Some data, however, suggest that despite

sarily be extrapolated to lower risk populations or to

higher vascular complications, there is currently a

patients who receive newer generation valves. We

lower impact on mortality due to the ability to

recently reported sex-specific outcomes of TAVR in

address and repair most of these complications by

the PARTNER IIA S3 high-risk and intermediate-risk

using an endovascular approach (4). Female patients

cohorts at the 2016 Transcatheter Cardiovascular

also had better initial left ventricular function and,

Therapeutics conference (6). In this high-risk and

after valve implantation, had a better cover index

intermediate-risk cohort, there was no difference at

than male patients. It should also be noted that most

1 year in survival or any other major outcome be-

of the patients in this study population had the

tween female and male patients despite a continued

balloon-expandable valve (Edwards Sapien, Edwards

higher incidence in procedural vascular complica-

Lifesciences, Irvine, California) and that the second-

tions in female patients. Why this better survival

generation Sapien XT 29 valve was not available

benefit that was seen in higher risk female patients

during most of the time period of this study. Thus,

undergoing TAVR may not be present in lower risk

only 12% of male patients received the 29-mm valve

female TAVR patients is not readily apparent. Thus,

in this study compared with the PARTNER IIA

the survival advantage of being female may not

(Placement of Aortic Transcatheter Valves) Sapien

always be true.

3 cohort, in which 35% of the male patients received the

29-mm

valve

(6).

This

factor

could

Has technology and expertise in performing TAVR

have

eliminated the female survival advantage or is the

adversely affected male survival by causing both a

PARTNER III data just an anomaly? Time will only tell

higher incidence of patient prosthesis mismatch

as new evidence continues to be generated. As it

and significant paravavular leak. Lastly, there may

stands now, being female is truly an advantage.

be a difference in the myocardial structural changes between sexes because female patients are known to undergo greater regression of left ventricular

REPRINT REQUESTS AND CORRESPONDENCE: Dr.

hypertrophy after aortic valve replacement than

Molly Szerlip, Department of Interventional Cardiol-

male patients. Male patients with aortic stenosis

ogy, The Heart Hospital Baylor Plano, 4716 Alliance

have been shown to have more cardiac fibrosis as

Boulevard, Pavilion Two, Suite 340, Plano, Texas

a consequence of aortic stenosis and thus less

75093. E-mail: [email protected]

REFERENCES 1. Hayashida K, Morice MC, Chevalier B, et al. Sexrelated differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol 2012;59:566–71.

valve replacement: a cohort study. Ann Intern Med 2016;164:377–84.

2. Humphries KH, Toggweiler S, Rodes-Cabau J, et al. Sex differences in mortality after transcatheter aortic valve replacement for severe aortic stenosis. J Am Coll Cardiol 2012;60:882–6.

patient-level meta-analysis of 11,310 patients. J Am Coll Cardiol 2015;66:221–8.

4. O’Connor SA, Morice MC, Gilard M, et al. Revisiting sex equality with transcatheter aortic valve replacement outcomes: a collaborative,

6. Szerlip M, Gualano S, Holper E, et al. Sex-Specific Outcomes of TAVR with the Sapien 3 Valve: Insights From the PARTNER 2 S3 High-Risk and Intermediate Risk Cohorts. Presented at TCT 2016, Washington, DC. 7. Petrov G, Regitz-Zagrosek V, Lehmkuhl E, et al. Regression of myocardial hypertrophy after aortic valve replacement: faster in women? Circulation 2010;122 Suppl 11:S23–8.

3. Kodali S, Williams MR, Doshi D, et al. Sexspecific differences at presentation and outcomes

5. Chandrasekhar J, Dangas G, Yu J, et al. Sex-based differences in outcomes with transcatheter aortic valve therapy: TVT registry from 2011 to 2014. J Am Coll Cardiol 2016;68:

among patients undergoing transcatheter aortic

2733–44.

risk TAVR, sex differences in TAVR

KEY WORDS Edwards Sapien 3, intermediate