Philippe Généreux1, David J Cohen2, Mathew R Williams3, Michael Mack4, Susheel K Kodali5, Lars G Svensson6, Ajay J Kirtane5, Ke Xu7, Thomas C McAndrew7, Raj Makkar8, Craig R Smith3, Martin B Leon9. 1. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. 2. Saint Luke's Mid America Heart Institute, Kansas City, Missouri. 3. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York. 4. Baylor Healthcare System, Plano, Texas. 5. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York. 6. Cleveland Clinic Foundation, Cleveland, Ohio. 7. Cardiovascular Research Foundation, New York, New York. 8. Cedars Sinai Medical Center, Los Angeles, California. 9. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: mleon@crf.org.
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).
RCT Entities:
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 stenosispatients 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).
Authors: Yoginee Sritharen; Maurice Enriquez-Sarano; Hartzell V Schaff; Grace Casaclang-Verzosa; Jordan D Miller Journal: Physiology (Bethesda) Date: 2017-05
Authors: Adam B Greenbaum; Vasilis C Babaliaros; Marcus Y Chen; Annette M Stine; Toby Rogers; William W O'Neill; Gaetano Paone; Vinod H Thourani; Kamran I Muhammad; Robert A Leonardi; Stephen Ramee; James F Troendle; Robert J Lederman Journal: J Am Coll Cardiol Date: 2016-10-29 Impact factor: 24.094
Authors: Björn Redfors; Brendan M Watson; Thomas McAndrew; Emilie Palisaitis; Dominic P Francese; Mehdi Razavi; Jordan Safirstein; Roxana Mehran; Ajay J Kirtane; Philippe Généreux Journal: JAMA Cardiol Date: 2017-07-01 Impact factor: 14.676
Authors: Md Tausif Salim; Joan Fernández Esmerats; Sivakkumar Arjunon; Nicolas Villa-Roel; Robert M Nerem; Hanjoong Jo; Ajit P Yoganathan Journal: Ann Biomed Eng Date: 2019-01-22 Impact factor: 3.934
Authors: Jayendrakumar S Patel; Amar Krishnaswamy; Lars G Svensson; E Murat Tuzcu; Stephanie Mick; Samir R Kapadia Journal: Curr Cardiol Rep Date: 2016-11 Impact factor: 2.931