Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement

Insights from the PARTNER i trial (Placement of Aortic Transcatheter Valve)

Philippe Genereux, David J. Cohen, Mathew R. Williams, Michael Mack, Susheel K. Kodali, Lars G. Svensson, Ajay J. Kirtane, Ke Xu, Thomas C. McAndrew, Raj Makkar, Craig R. Smith, Martin B. Leon

Research output: Contribution to journalArticle

89 Citations (Scopus)

Abstract

Objectives This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). Background Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. Methods In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. Results A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9%) than either TF-TAVR (7.1%) or TA-TAVR (4.8%; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR. Conclusions Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

Original languageEnglish (US)
Pages (from-to)1100-1109
Number of pages10
JournalJournal of the American College of Cardiology
Volume63
Issue number11
DOIs
StatePublished - Mar 25 2014
Externally publishedYes

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Aortic Valve
Surgical Instruments
Hemorrhage
Mortality
Transcatheter Aortic Valve Replacement
Conversion to Open Surgery
Aortic Valve Stenosis
Blood Vessels
Hemoglobins
Hemodynamics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Genereux, Philippe ; Cohen, David J. ; Williams, Mathew R. ; Mack, Michael ; Kodali, Susheel K. ; Svensson, Lars G. ; Kirtane, Ajay J. ; Xu, Ke ; McAndrew, Thomas C. ; Makkar, Raj ; Smith, Craig R. ; Leon, Martin B. / Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement : Insights from the PARTNER i trial (Placement of Aortic Transcatheter Valve). In: Journal of the American College of Cardiology. 2014 ; Vol. 63, No. 11. pp. 1100-1109.
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title = "Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: Insights from the PARTNER i trial (Placement of Aortic Transcatheter Valve)",
abstract = "Objectives This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). Background Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. Methods In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. Results A total of 71 (22.7{\%}), 27 (11.3{\%}), and 9 (8.8{\%}) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9{\%}) than either TF-TAVR (7.1{\%}) or TA-TAVR (4.8{\%}; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR. Conclusions Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)",
author = "Philippe Genereux and Cohen, {David J.} and Williams, {Mathew R.} and Michael Mack and Kodali, {Susheel K.} and Svensson, {Lars G.} and Kirtane, {Ajay J.} and Ke Xu and McAndrew, {Thomas C.} and Raj Makkar and Smith, {Craig R.} and Leon, {Martin B.}",
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language = "English (US)",
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Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement : Insights from the PARTNER i trial (Placement of Aortic Transcatheter Valve). / Genereux, Philippe; Cohen, David J.; Williams, Mathew R.; Mack, Michael; Kodali, Susheel K.; Svensson, Lars G.; Kirtane, Ajay J.; Xu, Ke; McAndrew, Thomas C.; Makkar, Raj; Smith, Craig R.; Leon, Martin B.

In: Journal of the American College of Cardiology, Vol. 63, No. 11, 25.03.2014, p. 1100-1109.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement

T2 - Insights from the PARTNER i trial (Placement of Aortic Transcatheter Valve)

AU - Genereux, Philippe

AU - Cohen, David J.

AU - Williams, Mathew R.

AU - Mack, Michael

AU - Kodali, Susheel K.

AU - Svensson, Lars G.

AU - Kirtane, Ajay J.

AU - Xu, Ke

AU - McAndrew, Thomas C.

AU - Makkar, Raj

AU - Smith, Craig R.

AU - Leon, Martin B.

PY - 2014/3/25

Y1 - 2014/3/25

N2 - Objectives This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). Background Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. Methods In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. Results A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9%) than either TF-TAVR (7.1%) or TA-TAVR (4.8%; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR. Conclusions Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

AB - Objectives This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). Background Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. Methods In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. Results A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9%) than either TF-TAVR (7.1%) or TA-TAVR (4.8%; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR. Conclusions Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

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DO - 10.1016/j.jacc.2013.10.058

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JF - Journal of the American College of Cardiology

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