Author + information
- Received March 3, 2017
- Revision received May 31, 2017
- Accepted July 2, 2017
- Published online November 20, 2017.
- Juan A. Crestanello, MDa,∗ (, )
- Jeffrey J. Popma, MDb,
- David H. Adams, MDc,
- G. Michael Deeb, MDd,
- Mubashir Mumtaz, MDe,
- Barry George, MDa,
- Jian Huang, MD, MScf and
- Michael J. Reardon, MDg
- aDivison of Cardiac Surgery, Wexner Medical Center, The Ohio State University, Columbus, Ohio
- bThe Departments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery), Beth Israel Deaconess Medical Center, Boston, Massachusetts
- cDepartment of Cardiovascular Surgery, Mount Sinai Health System, New York, New York
- dDepartment of Cardiac Surgery, University of Michigan Medical Center, Ann Arbor, Michigan
- eDepartment of Cardiovascular and Thoracic Surgery, Pinnacle Health, Harrisburg, Pennsylvania
- fStatistical Services, Medtronic, Minneapolis, Minnesota
- gDepartment of Cardiac Surgery, Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas
- ↵∗Address for correspondence:
Dr. Juan A. Crestanello, Division of Cardiac Surgery, Heart and Vascular Center, Wexner Medical Center, The Ohio State University, 410 West 10th Avenue, Doan N825, Columbus, Ohio 43210.
Objectives This study sought to characterize the long-term effect of chronic lung disease (CLD) on mortality, clinical outcomes, quality of life, and health benefits after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis.
Background The long-term effect of CLD after TAVR is unknown.
Methods Prevalence and severity of CLD was determined at baseline in high- and extreme-risk patients with aortic stenosis from the CoreValve US Pivotal Trial. Clinical outcomes and health status were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS). A favorable health benefit was defined as alive with a KCCQ-OS ≥60 and stability (<10-point decrease) or improvement in the KCCQ-OS from baseline.
Results CLD was present in 55% (20% mild, 13% moderate, 22% severe) of the 1,030 patients studied. All-cause mortality was higher in patients with moderate and severe CLD at 1 year (19.6% mild, 28.1% moderate, 26.9% severe CLD vs. 19.2% non-CLD; p = 0.030) and 3 years (44.8% mild, 53.0% moderate, 51.9% severe vs. 37.7% non-CLD; p < 0.001). New York Heart Association functional class improved in more than 80% of patients with CLD at 1 and 3 years. All patients had a nearly 20-point improvement in KCCQ-OS at 1 and 3 years. However, only 43.3% of patients with CLD had a favorable health benefit at 1 year and 22.5% at 3 years.
Conclusions Moderate and severe CLD increases 1- and 3-year mortality after TAVR. Although functional status and quality of life were improved in CLD at 1 and 3 years after TAVR, a favorable health benefit was only achieved in selected patients. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)
- chronic lung disease
- chronic obstructive pulmonary disease
- clinical outcomes
- Kansas City Cardiomyopathy Questionnaire
- quality of life
- transcatheter aortic valve replacement
This work was funded by Medtronic, Minneapolis, Minnesota. Dr. Crestanello serves on a medical advisory board and has received research grants from Medtronic. Dr. Popma has received grant support to his institution from Medtronic, Boston Scientific, Abbott, and Direct Flow Medical; has served on the medical advisory board for Boston Scientific; and has served as a consultant for Direct Flow Medical. Dr. Adams reports that the Icahn School of Medicine at Mount Sinai receives royalty payments from Medtronic for intellectual property related to Dr. Adam’s involvement in the development of a tricuspid repair ring; the Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences for intellectual property related to Dr. Adam’s involvement in the development of 2 mitral repair rings; serves as the national co-principal investigator of the Medtronic CoreValve US Pivotal Trial; serves as the national co-principal investigator of the Medtronic Twelve Intrepid TMVR Pivotal Study; and serves as the National co-principal investigator of the NeoChord DS1000 System Study. Dr. Deeb has served on an advisory board and as a proctor for Medtronic; is a consultant and research investigator for Edwards Lifesciences; is a consultant and proctor for Terumo; is a research investigator for Gore Medical; served as an investigator in the Pivotal Trial; and served on the screening and steering committee for the Pivotal Trials with Medtronic. Dr. Mumtaz has received consulting fees, proctoring fees, honoraria, and research support from Abbott, Atricure, Direct Flow Medical, Edwards Lifesciences, and Medtronic. Dr. Huang is an employee and shareholder of Medtronic. Dr. Reardon serves on a medical advisory board for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 3, 2017.
- Revision received May 31, 2017.
- Accepted July 2, 2017.
- 2017 American College of Cardiology Foundation