Author + information
- Received July 26, 2017
- Revision received September 26, 2017
- Accepted September 28, 2017
- Published online January 1, 2018.
- Molly Szerlip, MDa,∗ (, )
- Sarah Gualano, MDa,
- Elizabeth Holper, MDa,
- John J. Squiers, MDa,
- Jonathon M. White, MDb,
- Darshan Doshi, MDc,
- Mathew R. Williams, MDd,
- Rebecca T. Hahn, MDc,
- John G. Webb, MDe,
- Lars G. Svensson, MD, PhDb,
- Ajay J. Kirtane, MD, SMc,
- David J. Cohen, MD, MScif,
- Pamela S. Douglas, MDg,
- Maria C. Alu, MSc,
- Aaron Crowley, MAh,
- E. Murat Tuzcu, MDb,
- Raj R. Makkar, MDi,
- Howard C. Herrmann, MDj,
- Vasilis Babaliaros, MDk,
- Vinod H. Thourani, MDk,
- Martin B. Leon, MDc,
- Susheel K. Kodali, MDc and
- Michael J. Mack, MDa
- aDepartment of Cardiology, The Heart Hospital Baylor Plano, Plano, Texas
- bCleveland Clinic, Cleveland, Ohio
- cColumbia University Medical Center, New York, New York
- dNYU Langone Medical Center, New York, New York
- eSt. Paul’s Hospital, Vancouver, Canada
- fSaint Luke’s Mid America Heart Institute, Kansas City, Missouri
- gDuke Clinical Research Institute/Duke University Medical Center, Durham, North Carolina
- hCardiovascular Research Foundation, New York, New York
- iCedars-Sinai Medical Center, Los Angeles, California
- jUniversity of Pennsylvania, Philadelphia, Pennsylvania
- kEmory University, Atlanta, Georgia
- ↵∗Address for correspondence:
Dr. Molly Szerlip, The Heart Hospital Baylor Plano, 1100 Allied Drive, Plano, Texas 75093.
Objectives The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve.
Background A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown.
Methods The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex.
Results Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts.
Conclusions The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.
Dr. Holper has served as a proctor and on the scientific advisory board for Boston Scientific. Dr. White has served as a consultant for Edwards Lifesciences. Dr. Williams has served as a consultant for and received research funding from Edwards Lifesciences. Dr. Hahn has had echocardiographic core lab contracts with Edwards Lifesciences (no direct compensation). Dr. Webb has served as a consultant for Edwards Lifesciences; and a member of the PARTNER trial executive committee (no direct compensation). Dr. Svensson owns equity in Cardiosolution and Valvexchange as well as intellectual property with Postthorax; has served as a member of the PARTNER trial executive committee (no direct compensation); and has served as the chairman of the PARTNER trial publications office. Dr. Kirtane has received institutional research grant support from Boston Scientific, Abbott Vascular, Medtronic, Abiomed, Eli Lilly, CathWorks, Philips, Siemens, and Spectranetics. Dr. Douglas has received institutional grant support from Edwards Lifesciences and has had echocardiographic core lab contracts with Edwards Lifesciences (no direct compensation). Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific; and has served as a consultant for Edwards Lifesciences and Medtronic. Ms. Alu has served as a consultant for Claret Medical. Dr. Tuzcu has served as a member of the PARTNER Trial Executive Committee (no direct compensation). Dr. Makkar has received grants from Edwards Lifesciences and has served as a consultant for Abbott Vascular, Cordis, and Medtronic. Dr. Herrmann has received institutional grant support from Edwards Lifesciences, Medtronic, St. Jude Medical, Boston Scientific, Bayer, and Abbott Vascular; and has served as a consultant for Edwards Lifesciences. Dr. Babaliaros has served as a consultant for Abbott Vascular and Edwards Lifesciences. Dr. Thourani has served as a consultant for Edwards Lifesciences. Dr. Leon has served as a member of the PARTNER trial executive committee (no direct compensation). Dr. Kodali has served as a consultant and on the steering committee for Edwards Lifesciences; has served on the scientific advisory board for Thubrikar Aortic Valve, Inc., and Dura Biotech; and owns equity in Thubrikar Aortic Valve, Inc. Dr. Mack has served as a member of the PARTNER trial executive committee (no direct compensation) and as the co-principal investigator of the Edwards Lifesciences PARTNER III trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 26, 2017.
- Revision received September 26, 2017.
- Accepted September 28, 2017.
- 2018 American College of Cardiology Foundation