TY - JOUR
T1 - Vascular complications after transcatheter aortic valve replacement
T2 - Insights from the PARTNER (placement of AoRTic TraNscathetER valve) trial
AU - Généreux, Philippe
AU - Webb, John G.
AU - Svensson, Lars G.
AU - Kodali, Susheel K.
AU - Satler, Lowell F.
AU - Fearon, William F.
AU - Davidson, Charles J.
AU - Eisenhauer, Andrew C.
AU - Makkar, Raj R.
AU - Bergman, Geoffrey W.
AU - Babaliaros, Vasilis
AU - Bavaria, Joseph E.
AU - Velazquez, Omaida C.
AU - Williams, Mathew R.
AU - Hueter, Irene
AU - Xu, Ke
AU - Leon, Martin B.
N1 - Funding Information:
The PARTNER trial was funded by Edwards Lifesciences and designed collaboratively by the Steering Committee and the sponsor. The present analysis was carried out by academic investigators at the Cardiovascular Research Foundation. Dr. Généreux has received speaker honoraria, consulting fees, and research grant from Edwards Lifesciences . Dr. Webb has received consulting fees from Edwards Lifesciences, as well as travel reimbursement for activities related to his participation on the Executive Committee of the PARTNER trial. Dr. Svensson has received travel reimbursement from Edwards Lifesciences for activities related to his participation on the Executive Committee of the PARTNER trial. Dr. Kodali has received consulting fees from Edwards Lifesciences and Medtronic; and is a member of the Scientific Advisory Board of Thubrikar Aortic Valve, Inc., the Medical Advisory Board of Paieon Medical, and the TAVI Advisory Board of St. Jude Medical. Dr. Davidson received grant support and consulting fees from Edwards Lifesciences . Dr. Fearon has received travel reimbursement from Edwards Lifesciences for activities related to his participation on the Steering Committee of the PARTNER 2 trial. Dr. Makkar has received grant support and travel reimbursements from Edwards Lifesciences ; consulting fees from Cordis, Medtronic, Abbott Vascular, Entourage Medical Technologies, and Abiomed; and lecture honoraria from Eli Lilly. Dr. Babaliaros has received consulting fees from DirectFlow Medical, Symetis, and St. Jude Medical. Dr. Williams has received consulting fees from Edwards Lifesciences. Dr. Leon is a nonpaid member of the Scientific Advisory Board of Edwards Lifesciences; and has received travel reimbursement from Edwards for activities related to his participation on the Executive Committee of the PARTNER trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2012/9/18
Y1 - 2012/9/18
N2 - Objectives: This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR). Background: VC after TF-TAVR are frequent and may be associated with unfavorable prognosis. Methods: From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. Results: Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio [HR]: 2.31 [95% confidence interval (CI): 1.08 to 4.98], p = 0.03). Major VC (HR: 2.31 [95% CI: 1.20 to 4.43], p = 0.012), and renal disease at baseline (HR: 2.26 [95% CI: 1.34 to 3.81], p = 0.002) were identified as independent predictors of 1-year mortality. Conclusions: Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.
AB - Objectives: This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR). Background: VC after TF-TAVR are frequent and may be associated with unfavorable prognosis. Methods: From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. Results: Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio [HR]: 2.31 [95% confidence interval (CI): 1.08 to 4.98], p = 0.03). Major VC (HR: 2.31 [95% CI: 1.20 to 4.43], p = 0.012), and renal disease at baseline (HR: 2.26 [95% CI: 1.34 to 3.81], p = 0.002) were identified as independent predictors of 1-year mortality. Conclusions: Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.
KW - TAVI
KW - TAVR
KW - aortic stenosis
KW - vascular complication
UR - http://www.scopus.com/inward/record.url?scp=84866097368&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84866097368&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2012.07.003
DO - 10.1016/j.jacc.2012.07.003
M3 - Article
C2 - 22883632
AN - SCOPUS:84866097368
SN - 0735-1097
VL - 60
SP - 1043
EP - 1052
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 12
ER -