TY - JOUR
T1 - Surgical versus percutaneous femoral access for delivery of large-bore cardiovascular devices (from the PARTNER Trial)
AU - McCabe, James M.
AU - Huang, Pei Hsiu
AU - Cohen, David J.
AU - Blackstone, Eugene H.
AU - Welt, Frederick G.P.
AU - Davidson, Michael J.
AU - Kaneko, Tsuyoshi
AU - Eng, Marvin H.
AU - Allen, Keith B.
AU - Xu, Ke
AU - Lowry, Ashley M.
AU - Lei, Yang
AU - Rajeswaran, Jeevanantham
AU - Brown, David L.
AU - Mack, Michael J.
AU - Webb, John G.
AU - Smith, Craig R.
AU - Leon, Martin B.
AU - Eisenhauer, Andrew C.
N1 - Funding Information:
Role of the Funding Source: The PARTNER trial was funded by Edwards Lifesciences and the protocol was collaboratively designed by the Sponsor and Steering Committee. Data used for this study were from a July 2013 locked data extract from Edwards Lifesciences to the PARTNER Publications Office. Data analysis was performed by investigators at Cleveland Clinic, with no sponsor involvement in the study proposal and design for this substudy, analysis, interpretation, or the decision to publish.
Publisher Copyright:
© 2016 Elsevier Inc. All rights reserved.
PY - 2016/5/15
Y1 - 2016/5/15
N2 - It is unclear if surgical exposure confers a risk advantage compared with a percutaneous approach for patients undergoing endovascular procedures requiring large-bore femoral artery access. From the randomized controlled Placement of Aortic Transcatheter Valve trials A and B and the continued access registries, a total of 1,416 patients received transfemoral transcatheter aortic valve replacement, of which 857 underwent surgical, and 559 underwent percutaneous access. Thirty-day rates of major vascular complications and quality of life scores were assessed. Propensity matching was used to adjust for unmeasured confounders. Overall, there were 116 major vascular complications (8.2%). Complication rates decreased dramatically during the study period. In unadjusted analysis, major vascular complications were significantly less common in the percutaneous access group (35 [6.3%] vs 81 [9.5%] p = 0.032). However, among 292 propensity-matched pairs, there was no difference in major vascular complications (22 [7.5%] vs 28 [9.6%], p = 0.37). Percutaneous access was associated with fewer total in-hospital vascular complications (46 [16%] vs 66 [23%], p = 0.036), shorter median procedural duration (97 interquartile range [IQR 68 to 166] vs 121 [IQR 78 to 194] minutes, p <0.0001), and median length of stay (4 [IQR 2 to 8] vs 6 [IQR 3 to 10] days, p <0.0001). There were no significant differences in quality of life scores at 30 days. Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications.
AB - It is unclear if surgical exposure confers a risk advantage compared with a percutaneous approach for patients undergoing endovascular procedures requiring large-bore femoral artery access. From the randomized controlled Placement of Aortic Transcatheter Valve trials A and B and the continued access registries, a total of 1,416 patients received transfemoral transcatheter aortic valve replacement, of which 857 underwent surgical, and 559 underwent percutaneous access. Thirty-day rates of major vascular complications and quality of life scores were assessed. Propensity matching was used to adjust for unmeasured confounders. Overall, there were 116 major vascular complications (8.2%). Complication rates decreased dramatically during the study period. In unadjusted analysis, major vascular complications were significantly less common in the percutaneous access group (35 [6.3%] vs 81 [9.5%] p = 0.032). However, among 292 propensity-matched pairs, there was no difference in major vascular complications (22 [7.5%] vs 28 [9.6%], p = 0.37). Percutaneous access was associated with fewer total in-hospital vascular complications (46 [16%] vs 66 [23%], p = 0.036), shorter median procedural duration (97 interquartile range [IQR 68 to 166] vs 121 [IQR 78 to 194] minutes, p <0.0001), and median length of stay (4 [IQR 2 to 8] vs 6 [IQR 3 to 10] days, p <0.0001). There were no significant differences in quality of life scores at 30 days. Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications.
UR - http://www.scopus.com/inward/record.url?scp=84962304141&partnerID=8YFLogxK
U2 - 10.1016/j.amjcard.2016.02.041
DO - 10.1016/j.amjcard.2016.02.041
M3 - Article
C2 - 27036077
AN - SCOPUS:84962304141
SN - 0002-9149
VL - 117
SP - 1643
EP - 1650
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 10
ER -