Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes. 

 -  2015 
<br/><br/>Available online from MWHC library: 1996 - present (after 1 year), Available in print through MWHC library: 1999 - 2006 
<br/><br/> 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.  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 and moderate/severe PVR predicted higher 1-year mortality.Copyright Published on behalf of the European Society of Cardiology. All rights reserved. � The Author 2014. For permissions please email: journals.permissions@oup.com.  METHODS AND RESULTS: Clinical and echocardiographic outcomes of patients who underwent TAVR from the randomized cohorts and continued access registries in the PARTNER trial were analysed after stratifying by severity of post-implant PVR, which was graded as none/trace in 52.9% (n = 1288), mild in 38.0% (n = 925), and moderate/severe in 9.1% (n = 221). There were 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 regression was 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, and moderate/severe). At 1 year, there was 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. 
<br/><br/><br/>English 
<br/><br/><label>ISSN: </label>1522-9645 
<br/><br/><label>Subjects--Topical Terms: </label><br/>*Aortic Valve Stenosis/su [Surgery]<br/>*Transcatheter Aortic Valve Replacement/is [Instrumentation]<br/>Aged, 80 and over<br/>Aortic Valve Insufficiency/et [Etiology]<br/>Aortic Valve Insufficiency/mo [Mortality]<br/>Aortic Valve Insufficiency/pa [Pathology]<br/>Aortic Valve Stenosis/mo [Mortality]<br/>Aortic Valve Stenosis/pa [Pathology]<br/>Echocardiography<br/>Female<br/>Heart Valve Prolapse<br/>Humans<br/>Male<br/>Mitral Valve Insufficiency/et [Etiology]<br/>Mitral Valve Insufficiency/mo [Mortality]<br/>Mitral Valve Insufficiency/pa [Pathology]<br/>Organ Size<br/>Reoperation/sn [Statistics & Numerical Data]<br/>Transcatheter Aortic Valve Replacement/ae [Adverse Effects]<br/>Transcatheter Aortic Valve Replacement/mt [Methods]<br/>Treatment Outcome
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Heart & Vascular Institute
<br/><br/><label>Index Terms--Function: </label><br/>Comparative Study<br/>Journal Article<br/>Multicenter Study<br/>Randomized Controlled Trial<br/>Research Support, Non-U.S. Gov't