Author + information
- Received December 13, 2018
- Revision received April 11, 2019
- Accepted April 16, 2019
- Published online September 16, 2019.
- Andres M. Pineda, MDa,∗ (, )
- J. Kevin Harrison, MDb,
- Neal S. Kleiman, MDc,
- Charanjit S. Rihal, MDd,
- Sucheel K. Kodali, MDe,
- Ajay J. Kirtane, MDe,
- Martin B. Leon, MDe,
- Matthew W. Sherwood, MDf,
- Pratik Manandhar, MSg,
- Sreekanth Vemulapalli, MDg and
- Nirat Beohar, MDh
- aDivision of Cardiology, Department of Medicine, University of Florida College of Medicine Jacksonville, Jacksonville, Florida
- bDepartment of Medicine, Duke University Medical Center, Durham, North Carolina
- cDepartment of Cardiology, Houston Methodist Hospital, Houston, Texas
- dDivision of Cardiology, Department of Medicine, Mayo Clinic, Rochester, Minnesota
- eDivision of Cardiology, Department of Medicine, Columbia University Medical Center, New York, New York
- fDivision of Cardiology, Inova Heart and Vascular Institute, Fairfax, Virginia
- gDuke Clinical Research Institute, Durham, North Carolina
- hColumbia University Division of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida
- ↵∗Address for correspondence:
Dr. Andres M. Pineda, University of Florida College of Medicine Jacksonville, Division of Cardiology, 655 West 8th Street, Jacksonville, Florida 32209.
Objectives The aim of this study was to evaluate the incidence and outcomes of surgical bailout during transcatheter aortic valve replacement (TAVR).
Background The incidence and outcomes of unplanned conversion to open heart surgery, or “surgical bailout,” during TAVR are not well characterized.
Methods Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was analyzed with respect to whether surgical bailout was performed during the index TAVR procedure. A Cox proportional hazards models was used to evaluate 1-year mortality and major adverse cardiovascular events.
Results Between November 2011 and September 2015, a total of 47,546 patients underwent TAVR. Surgical bailout during TAVR was performed in 1.17% of the cases (n = 558); the most frequent indications were valve dislodgement (22%), ventricular rupture (19.9%), and aortic valve annular rupture (14.2%). The incidence of surgical bailout significantly decreased over time (first tertile 1.25%, second tertile 1.43%, third tertile 1.04%; p = 0.0088). The 30-day and 1-year incidence of major adverse cardiovascular events (54.6% vs. 7.4% [p < 0.0001] and 63.92% vs. 20.29% [p < 0.0001]) and all-cause mortality (50.00% vs. 4.98% [p < 0.0001] and 59.79% vs. 17.06% [p < 0.0001]) were significantly higher in those who underwent bailout. Independent predictors of surgical bailout included female sex, hemoglobin, left ventricular ejection fraction, nonelective cases, and nonfemoral access. Body surface area was the only independent predictor of survival after surgical bailout.
Conclusions In a large, nationally representative registry, the need for surgical bailout in patients undergoing TAVR is low, and its incidence has decreased over time. However, surgical bailout after TAVR is associated with poor outcomes, including 50% mortality at 30 days.
Dr. Pineda has received consulting fees from Pfizer and TZ Medical. Dr. Harrison has received institutional grants from Abbott Vascular, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr. Kleiman has received fees from Medtronic for providing educational services. Dr. Rihal has received institutional grants from Medtronic and Edwards Lifesciences. Dr. Kodali received research grants from Claret Medical, Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, Admedus, and Meril Life Sciences; is on the scientific advisory board for Thubrikar Aortic Valve Inc., Dura Biotech, and Biotrace Medical; received honoraria from Claret Medical, Admedus, Meril Life Sciences, and Abbott Vascular; and received equity from Thubrikar Aortic Valve Inc., Dura Biotech, and Biotrace Medical. Dr. Kirtane has received institutional grants from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems, Inc., CathWorks, Siemens, Philips, and ReCor Medical. Dr. Leon has received institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Sherwood has received consulting fees from Medtronic. Dr. Vemulapalli has received institutional grants from the American College of Cardiology and the Society of Thoracic Surgeons; has received personal grants from Abbott Vascular, the Patient-Centered Outcomes Research Institute, National Institutes of Health, and Boston Scientific; and has received consulting fees from Boston Scientific, Novella, Janssen, and Premiere. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 13, 2018.
- Revision received April 11, 2019.
- Accepted April 16, 2019.
- 2019 American College of Cardiology Foundation
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