Susheel Kodali, MD; Mathew R. Williams, MD; Darshan Doshi, MD, MS; Rebecca T. Hahn, MD; Karin H. Humphries, DSc; Vuyisile T. Nkomo, MD, MPH; David J. Cohen, MD, MSc; Pamela S. Douglas, MD; Michael Mack, MD; Ke Xu, PhD; Lars Svensson, MD, PhD; Vinod H. Thourani, MD; E. Murat Tuzcu, MD; Neil J. Weissman, MD; Martin Leon, MD; Ajay J. Kirtane, MD, SM
Acknowledgment: The authors thank Maria Alu and Girma M. Ayele, PhD, for assistance with preparation of this manuscript.
Financial Support: The PARTNER trial was funded by Edwards Lifesciences and designed collaboratively by the steering committee and the sponsor. All data analyses were done independently at the Cardiovascular Research Foundation (New York, New York) and were supported by an unrestricted research grant from Edwards Lifesciences. The authors had unrestricted access to the study data, drafted the manuscript, made the decision to submit it for publication, and guarantee the completeness and accuracy of its content.
Disclosures: Dr. 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. Williams reports a consultancy for Edwards Lifesciences outside the submitted work. Dr. Hahn reports speaker honoraria from St. Jude Medical, Boston Scientific, Edwards Lifesciences, and Philips Medical outside the submitted work. Dr. Cohen reports grants from Edwards Lifesciences during the conduct of the study and outside the submitted work and grants and personal fees from Medtronic outside the submitted work. Dr. Douglas reports grants from Edwards Lifesciences during the conduct of the study. Dr. Weissman reports grants from Edwards Lifesciences during the conduct of the study and grants from Boston Scientific, Abbott Vascular, St. Jude Medical, Medtronic, Sorin Medical, and Direct Flow Medical 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. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0121.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol and statistical code: Available to approved persons through written agreement with the authors (e-mail, firstname.lastname@example.org). Data set: Not available.
Requests for Single Reprints: Susheel Kodali, MD, Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032; e-mail, email@example.com.
Current Author Addresses: Drs. Kodali, Doshi, Hahn, Leon, and Kirtane: Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032.
Dr. Williams: NYU Langone Medical Center, 530 First Avenue, Suite 9V, New York, NY 10016.
Dr. Humphries: University of British Columbia, Center for Health Evaluation and Outcome Sciences, St. Paul's Hospital, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
Dr. Nkomo: Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Dr. Cohen: Saint Luke's Mid-America Heart Institute, 4401 Wornall Road, Kansas City, MO 64111.
Dr. Douglas: Duke Clinical Research Institute, 7022 North Pavilion DUMC, Durham, NC 27715.
Dr. Mack: Baylor Scott & White Health, 1100 Allied Drive, Plano, TX 75093.
Dr. Xu: Cardiovascular Research Foundation, 111 East 59th Street, 12th Floor, New York, NY 10022.
Drs. Svensson and Tuzcu: Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195.
Dr. Thourani: Emory University Hospital Midtown, 550 Peachtree Street NE, 6th Floor MOT, Cardiac Surgery, Atlanta, GA 30308.
Dr. Weissman: MedStar Health Research Institute, 100 Irving Street, Suite EB 5123, Washington, DC 20010.
Author Contributions: Conception and design: S. Kodali, M.R. Williams, D. Doshi, M. Mack, L. Svensson, V.H. Thourani, M. Leon, A.J. Kirtane.
Analysis and interpretation of the data: S. Kodali, M.R. Williams, D. Doshi, K.H. Humphries, D.J. Cohen, P.S. Douglas, M. Mack, K. Xu, V.H. Thourani, E.M. Tuzcu, N.J. Weissman, M. Leon, A.J. Kirtane.
Drafting of the article: S. Kodali, M.R. Williams, D. Doshi, R.T. Hahn, V.T. Nkomo, M. Mack, M. Leon.
Critical revision of the article for important intellectual content: S. Kodali, M.R. Williams, D. Doshi, K.H. Humphries, V.T. Nkomo, D.J. Cohen, P.S. Douglas, M. Mack, L. Svensson, V.H. Thourani, E.M. Tuzcu, N.J. Weissman, M. Leon, A.J. Kirtane.
Final approval of the article: S. Kodali, M.R. Williams, D. Doshi, R.T. Hahn, K.H. Humphries, V.T. Nkomo, D.J. Cohen, P.S. Douglas, M. Mack, K. Xu, L. Svensson, V.H. Thourani, E.M. Tuzcu, N.J. Weissman, M. Leon, A.J. Kirtane.
Provision of study materials or patients: S. Kodali, M.R. Williams, P.S. Douglas.
Statistical expertise: D. Doshi, K. Xu.
Obtaining of funding: L. Svensson, N.J. Weissman.
Administrative, technical, or logistic support: E.M. Tuzcu, N.J. Weissman.
Collection and assembly of data: S. Kodali, M.R. Williams, D. Doshi, D.J. Cohen, P.S. Douglas, M. Mack, E.M. Tuzcu, N.J. Weissman, M. Leon.
Kodali S, Williams MR, Doshi D, Hahn RT, Humphries KH, Nkomo VT, et al. Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study. Ann Intern Med. 2016;164:377-384. doi: 10.7326/M15-0121
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Published: Ann Intern Med. 2016;164(6):377-384.
Published at www.annals.org on 23 February 2016
Female sex is associated with poorer outcomes after surgical aortic valve replacement (SAVR). Data on sex-specific differences after transcatheter aortic valve replacement (TAVR) are conflicting.
To examine sex-specific differences in patients undergoing TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial.
Secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. (ClinicalTrials.gov: NCT00530894)
25 hospitals in the United States, Canada, and Germany.
High-risk and inoperable patients (1220 women and 1339 men).
Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters.
At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease but higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (11.9% vs. 11.1%; P < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, −8.3 percentage points [CI, −11.7 to −5.0 percentage points]; P < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point [CI, −1.29 to 2.45 percentage points]; P = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point [CI, −0.62 to 2.19 percentage points]; P = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72 [CI, 0.61 to 0.85]; P < 0.001).
Secondary analysis that included nonrandomized trial data.
Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis.
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