TY - JOUR
T1 - Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial
T2 - Characterizing patients and impact on outcomes
AU - Kodali, Susheel
AU - Pibarot, Philippe
AU - Douglas, Pamela S.
AU - Williams, Mathew
AU - Xu, Ke
AU - Thourani, Vinod
AU - Rihal, Charanjit S.
AU - Zajarias, Alan
AU - Doshi, Darshan
AU - Davidson, Michael
AU - Tuzcu, E. Murat
AU - Stewart, William
AU - Weissman, Neil J.
AU - Svensson, Lars
AU - Greason, Kevin
AU - Maniar, Hersh
AU - Mack, Michael
AU - Anwaruddin, Saif
AU - Leon, Martin B.
AU - Hahn, Rebecca T.
N1 - Funding Information:
The PARTNER trial was supported by Edwards Lifesciences and the protocol was designed collaboratively by the Sponsor and the Steering Committee.
Funding Information:
Conflict of interest: S.K. has received consulting fees from Edwards Lifesciences and is a member of the Advisory Board of Thubrikar Aortic Valve. P.P. holds the Canada research Chair in Valvular Heart Diseases, Canadian Institutes of Health research, Ottawa, Ontario, Canada and has received grant support from Edwards Lifesciences. P.S.D.s’ institution has received research grant funding from Edwards Lifesciences. M.W. is a consultant for Edwards Lifesciences. V.T. has received consulting fees from Edwards Lifesciences, Sorin Medical, St Jude Medical, and DirectFlow. E.M.T. has received travel reimbursements from Edwards
Funding Information:
Lifesciences related to his work as an unpaid member of the PARTNER Trial Executive Committee. N.J.W. has received grant support from Boston Scientific Corporation. L.S. has received travel reimbursements from Edwards Lifesciences related to his work as an unpaid member of the PARTNER Trial Executive Committee, holds equity in Cardiosolu-tions and ValvXchange, and has Intellectual Property Rights/Royalties from Posthorax. M.M.and M.B.L. have received travel reimbursements from Edwards Lifesciences related to their work as unpaid members of the PARTNER Trial Executive Committee. R.T.H. has received consultant fees from Edwards Lifesciences and research support from Philips Healthcare. The other authors report no potential conflicts of interest.
Publisher Copyright:
© The Author 2014.
PY - 2015
Y1 - 2015
N2 - Aim The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) remains uncertain. In this analysis, we sought to evaluate the impact of varying degrees of PVR on both mortality and changes in ventricular geometry and function. Methods and results Clinical and echocardiographic outcomes of patientswhounderwentTAVRfromthe randomized cohorts and continued access registries in the PARTNERtrialwere analysed after stratifying by severity of post-implant PVR, whichwas graded as none/trace in 52.9% (n = 1288), mild in 38.0% (n = 925), and moderate/severe in 9.1% (n = 221). Therewere significant differences in baseline clinical and echocardiographic characteristics. After TAVR, all the patients demonstrated increase in left ventricular (LV) function and reduction in the LV mass index, although the magnitude of mass regressionwas lower in the moderate/severe PVR group. The 30-day mortality (3.1 vs. 3.4 vs. 4.5%, P = 0.56) and stroke (3.4 vs. 3.7 vs. 2.3%, P = 0.59)were similar in all groups (none/trace, mild, andmoderate/severe). At 1 year, therewas increased all-cause mortality (15.9 vs. 22.2 vs. 35.1%, P < 0.0001), cardiac mortality (6.1 vs. 7.4% vs. 16.3%, P < 0.0001) and re-hospitalization (14.4 vs. 23.0 vs. 31.3%, P < 0.0001) with worsening PVR. A multivariable analysis indicated that the presence of moderate/severe PVR (HR: 2.18, 95% CI: 1.57-3.02, P < 0.0001) or mild PVR (HR: 1.37, 95% CI: 1.14-1.90, P = 0.012) was associated with higher late mortality. Conclusion Differences in baseline characteristics in patients with increasing severities of PVR may increase the risk of this complication. Despite these differences, multivariable analysis demonstrated that both mild andmoderate/severePVRpredicted higher 1-year mortality.
AB - Aim The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) remains uncertain. In this analysis, we sought to evaluate the impact of varying degrees of PVR on both mortality and changes in ventricular geometry and function. Methods and results Clinical and echocardiographic outcomes of patientswhounderwentTAVRfromthe randomized cohorts and continued access registries in the PARTNERtrialwere analysed after stratifying by severity of post-implant PVR, whichwas graded as none/trace in 52.9% (n = 1288), mild in 38.0% (n = 925), and moderate/severe in 9.1% (n = 221). Therewere significant differences in baseline clinical and echocardiographic characteristics. After TAVR, all the patients demonstrated increase in left ventricular (LV) function and reduction in the LV mass index, although the magnitude of mass regressionwas lower in the moderate/severe PVR group. The 30-day mortality (3.1 vs. 3.4 vs. 4.5%, P = 0.56) and stroke (3.4 vs. 3.7 vs. 2.3%, P = 0.59)were similar in all groups (none/trace, mild, andmoderate/severe). At 1 year, therewas increased all-cause mortality (15.9 vs. 22.2 vs. 35.1%, P < 0.0001), cardiac mortality (6.1 vs. 7.4% vs. 16.3%, P < 0.0001) and re-hospitalization (14.4 vs. 23.0 vs. 31.3%, P < 0.0001) with worsening PVR. A multivariable analysis indicated that the presence of moderate/severe PVR (HR: 2.18, 95% CI: 1.57-3.02, P < 0.0001) or mild PVR (HR: 1.37, 95% CI: 1.14-1.90, P = 0.012) was associated with higher late mortality. Conclusion Differences in baseline characteristics in patients with increasing severities of PVR may increase the risk of this complication. Despite these differences, multivariable analysis demonstrated that both mild andmoderate/severePVRpredicted higher 1-year mortality.
KW - Aortic stenosis
KW - Paravalvular regurgitation
KW - Transcatheter aortic valve replacement
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U2 - 10.1093/eurheartj/ehu384
DO - 10.1093/eurheartj/ehu384
M3 - Article
C2 - 25273886
AN - SCOPUS:84964698835
VL - 36
SP - 449
EP - 456
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 7
ER -