TY - JOUR
T1 - Incidence and Outcomes of Surgical Bailout During TAVR
T2 - Insights From the STS/ACC TVT Registry
AU - Pineda, Andres M.
AU - Harrison, J. Kevin
AU - Kleiman, Neal S.
AU - Rihal, Charanjit S.
AU - Kodali, Sucheel K.
AU - Kirtane, Ajay J.
AU - Leon, Martin B.
AU - Sherwood, Matthew W.
AU - Manandhar, Pratik
AU - Vemulapalli, Sreekanth
AU - Beohar, N.
N1 - Funding Information:
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.
Publisher Copyright:
© 2019 American College of Cardiology Foundation
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/9/23
Y1 - 2019/9/23
N2 - 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.
AB - 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.
KW - TAVR
KW - complications
KW - mortality
KW - outcomes
KW - surgical bailout
KW - transcatheter aortic valve replacement
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U2 - 10.1016/j.jcin.2019.04.026
DO - 10.1016/j.jcin.2019.04.026
M3 - Article
C2 - 31537276
AN - SCOPUS:85071876301
SN - 1936-8798
VL - 12
SP - 1751
EP - 1764
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 18
ER -