Andres M Pineda1, J Kevin Harrison2, Neal S Kleiman3, Charanjit S Rihal4, Sucheel K Kodali5, Ajay J Kirtane5, Martin B Leon5, Matthew W Sherwood6, Pratik Manandhar7, Sreekanth Vemulapalli7, Nirat Beohar8. 1. Division of Cardiology, Department of Medicine, University of Florida College of Medicine Jacksonville, Jacksonville, Florida. Electronic address: andres.pinedamaldonado@jax.ufl.edu. 2. Department of Medicine, Duke University Medical Center, Durham, North Carolina. 3. Department of Cardiology, Houston Methodist Hospital, Houston, Texas. 4. Division of Cardiology, Department of Medicine, Mayo Clinic, Rochester, Minnesota. 5. Division of Cardiology, Department of Medicine, Columbia University Medical Center, New York, New York. 6. Division of Cardiology, Inova Heart and Vascular Institute, Fairfax, Virginia. 7. Duke Clinical Research Institute, Durham, North Carolina. 8. Columbia University Division of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida.
Abstract
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.
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.
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