Incidence and Outcomes of Surgical Bailout During TAVR: Insights From the STS/ACC TVT Registry

Andres M. Pineda, J. Kevin Harrison, Neal S. Kleiman, Charanjit Rihal, Sucheel K. Kodali, Ajay J. Kirtane, Martin B. Leon, Matthew W. Sherwood, Pratik Manandhar, Sreekanth Vemulapalli, N. Beohar

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1751-1764
Number of pages14
JournalJACC: Cardiovascular Interventions
Volume12
Issue number18
DOIs
StatePublished - Sep 23 2019

Fingerprint

Registries
Incidence
Therapeutics
Mortality
Rupture
Conversion to Open Surgery
Body Surface Area
Transcatheter Aortic Valve Replacement
Aortic Valve
Proportional Hazards Models
Stroke Volume
Thoracic Surgery
Hemoglobins
Survival

Keywords

  • complications
  • mortality
  • outcomes
  • surgical bailout
  • TAVR
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Pineda, A. M., Harrison, J. K., Kleiman, N. S., Rihal, C., Kodali, S. K., Kirtane, A. J., ... Beohar, N. (2019). Incidence and Outcomes of Surgical Bailout During TAVR: Insights From the STS/ACC TVT Registry. JACC: Cardiovascular Interventions, 12(18), 1751-1764. https://doi.org/10.1016/j.jcin.2019.04.026

Incidence and Outcomes of Surgical Bailout During TAVR : Insights From the STS/ACC TVT Registry. / Pineda, Andres M.; Harrison, J. Kevin; Kleiman, Neal S.; Rihal, Charanjit; Kodali, Sucheel K.; Kirtane, Ajay J.; Leon, Martin B.; Sherwood, Matthew W.; Manandhar, Pratik; Vemulapalli, Sreekanth; Beohar, N.

In: JACC: Cardiovascular Interventions, Vol. 12, No. 18, 23.09.2019, p. 1751-1764.

Research output: Contribution to journalArticle

Pineda, AM, Harrison, JK, Kleiman, NS, Rihal, C, Kodali, SK, Kirtane, AJ, Leon, MB, Sherwood, MW, Manandhar, P, Vemulapalli, S & Beohar, N 2019, 'Incidence and Outcomes of Surgical Bailout During TAVR: Insights From the STS/ACC TVT Registry', JACC: Cardiovascular Interventions, vol. 12, no. 18, pp. 1751-1764. https://doi.org/10.1016/j.jcin.2019.04.026
Pineda, Andres M. ; Harrison, J. Kevin ; Kleiman, Neal S. ; Rihal, Charanjit ; Kodali, Sucheel K. ; Kirtane, Ajay J. ; Leon, Martin B. ; Sherwood, Matthew W. ; Manandhar, Pratik ; Vemulapalli, Sreekanth ; Beohar, N. / Incidence and Outcomes of Surgical Bailout During TAVR : Insights From the STS/ACC TVT Registry. In: JACC: Cardiovascular Interventions. 2019 ; Vol. 12, No. 18. pp. 1751-1764.
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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.",
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AU - Harrison, J. Kevin

AU - Kleiman, Neal S.

AU - Rihal, Charanjit

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.

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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.

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KW - mortality

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KW - TAVR

KW - transcatheter aortic valve replacement

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