TY - JOUR
T1 - Reoperation After Transcatheter Aortic Valve Replacement
T2 - An Analysis of the Society of Thoracic Surgeons Database
AU - Jawitz, Oliver K.
AU - Gulack, Brian C.
AU - Grau-Sepulveda, Maria V.
AU - Matsouaka, Roland A.
AU - Mack, Michael J.
AU - Holmes, David R.
AU - Carroll, John D.
AU - Thourani, Vinod H.
AU - Brennan, J. Matthew
N1 - Funding Information:
The Society of Thoracic Surgeons National Database provided the data for this research. Analysis funding was provided by the Duke Clinical Research Institute and an Food and Drug Administration U01 grant (PI: Brennan). Dr. Jawitz has received funding provided by National Institutes of Health T-32 grant 5T32HL069749. Dr. Mack has served as a co-principal investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr. Carroll has served as a local investigator for Medtronic and Edwards Lifesciences. Dr. Brennan has served as a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Funding Information:
The Society of Thoracic Surgeons National Database provided the data for this research. Analysis funding was provided by the Duke Clinical Research Institute and an Food and Drug Administration U01 grant (PI: Brennan). Dr. Jawitz has received funding provided by National Institutes of Health T-32 grant 5T32HL069749. Dr. Mack has served as a co-principal investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr. Carroll has served as a local investigator for Medtronic and Edwards Lifesciences. Dr. Brennan has served as a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2020 American College of Cardiology Foundation
PY - 2020/7/13
Y1 - 2020/7/13
N2 - Objectives: This study sought to report the largest series of patients receiving a surgical reoperation after transcatheter aortic valve replacement (TAVR) using the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database. Background: TAVR has become an effective means of treating aortic stenosis. As TAVR is used in progressively lower-risk cohorts, management of device failure will become increasingly important. Methods: The STS Adult Cardiac Surgery Database was queried for patients with a history of prior TAVR undergoing surgical aortic valve replacement from 2011 to 2015. Observed-to-expected (O/E) mortality ratios were determined to facilitate comparison across reoperative indications and timing from index TAVR procedure. Results: A total of 123 patients met inclusion criteria (median age 77 years) with an STS Predicted Risk of Mortality of 4%, 4% to 8%, and >8% in 17%, 24%, and 59%, respectively. Median time to reoperation was 2.5 (interquartile range: 0.7 to 13.0) months, and the operative mortality rate was 17.1%. Common indications for reoperation included early TAVR device failures such as paravalvular leak (15%), structural prosthetic deterioration (11%), failed repair (11%), sizing or position issues (11%), and prosthetic valve endocarditis (10%). All pre-operative risk categories were associated with an increased O/E mortality ratio (Predicted Risk of Mortality <4%: O/E 5.5; 4% to 8%: O/E 1.7; >8%: O/E 1.2). Conclusions: SAVR following early failure of TAVR, while rare, is associated with worse-than-expected outcomes as compared with similar patients initially undergoing SAVR. Continued experience with this developing technology is needed to reduce the incidence of early TAVR failure and further define optimal treatment of failed TAVR prostheses.
AB - Objectives: This study sought to report the largest series of patients receiving a surgical reoperation after transcatheter aortic valve replacement (TAVR) using the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database. Background: TAVR has become an effective means of treating aortic stenosis. As TAVR is used in progressively lower-risk cohorts, management of device failure will become increasingly important. Methods: The STS Adult Cardiac Surgery Database was queried for patients with a history of prior TAVR undergoing surgical aortic valve replacement from 2011 to 2015. Observed-to-expected (O/E) mortality ratios were determined to facilitate comparison across reoperative indications and timing from index TAVR procedure. Results: A total of 123 patients met inclusion criteria (median age 77 years) with an STS Predicted Risk of Mortality of 4%, 4% to 8%, and >8% in 17%, 24%, and 59%, respectively. Median time to reoperation was 2.5 (interquartile range: 0.7 to 13.0) months, and the operative mortality rate was 17.1%. Common indications for reoperation included early TAVR device failures such as paravalvular leak (15%), structural prosthetic deterioration (11%), failed repair (11%), sizing or position issues (11%), and prosthetic valve endocarditis (10%). All pre-operative risk categories were associated with an increased O/E mortality ratio (Predicted Risk of Mortality <4%: O/E 5.5; 4% to 8%: O/E 1.7; >8%: O/E 1.2). Conclusions: SAVR following early failure of TAVR, while rare, is associated with worse-than-expected outcomes as compared with similar patients initially undergoing SAVR. Continued experience with this developing technology is needed to reduce the incidence of early TAVR failure and further define optimal treatment of failed TAVR prostheses.
KW - SAVR
KW - TAVR
KW - device failure
KW - surgical aortic valve replacement
KW - transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85086913461&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85086913461&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2020.04.029
DO - 10.1016/j.jcin.2020.04.029
M3 - Article
C2 - 32535005
AN - SCOPUS:85086913461
SN - 1936-8798
VL - 13
SP - 1515
EP - 1525
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 13
ER -