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Randomized Controlled Trial
. 2014 Jun;7(6):662-73.
doi: 10.1016/j.jcin.2014.02.011.

Early regression of severe left ventricular hypertrophy after transcatheter aortic valve replacement is associated with decreased hospitalizations

Brian R Lindman  1 , William J Stewart  2 , Philippe Pibarot  3 , Rebecca T Hahn  4 , Catherine M Otto  5 , Ke Xu  6 , Richard B Devereux  7 , Neil J Weissman  8 , Maurice Enriquez-Sarano  9 , Wilson Y Szeto  10 , Raj Makkar  11 , D Craig Miller  12 , Stamatios Lerakis  13 , Samir Kapadia  2 , Bruce Bowers  14 , Kevin L Greason  9 , Thomas C McAndrew  6 , Yang Lei  15 , Martin B Leon  16 , Pamela S Douglas  17
Affiliations
Randomized Controlled Trial

Early regression of severe left ventricular hypertrophy after transcatheter aortic valve replacement is associated with decreased hospitalizations

Brian R Lindman et al. JACC Cardiovasc Interv. 2014 Jun.

Abstract

Objectives: This study sought to examine the relationship between left ventricular mass (LVM) regression and clinical outcomes after transcatheter aortic valve replacement (TAVR).

Background: LVM regression after valve replacement for aortic stenosis is assumed to be a favorable effect of LV unloading, but its relationship to improved clinical outcomes is unclear.

Methods: Of 2,115 patients with symptomatic aortic stenosis at high surgical risk receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) randomized trial or continued access registry, 690 had both severe LV hypertrophy (left ventricular mass index [LVMi] ≥ 149 g/m(2) men, ≥ 122 g/m(2) women) at baseline and an LVMi measurement at 30-day post-TAVR follow-up. Clinical outcomes were compared for patients with greater than versus lesser than median percentage change in LVMi between baseline and 30 days using Cox proportional hazard models to evaluate event rates from 30 to 365 days.

Results: Compared with patients with lesser regression, patients with greater LVMi regression had a similar rate of all-cause mortality (14.1% vs. 14.3%, p = 0.99), but a lower rate of rehospitalization (9.5% vs. 18.5%, hazard ratio [HR]: 0.50, 95% confidence interval [CI]: 0.32 to 0.78; p = 0.002) and a lower rate of rehospitalization specifically for heart failure (7.3% vs. 13.6%, p = 0.01). The association with a lower rate of rehospitalization was consistent across subgroups and remained significant after multivariable adjustment (HR: 0.53, 95% CI: 0.34 to 0.84; p = 0.007). Patients with greater LVMi regression had lower B-type natriuretic peptide (p = 0.002) and a trend toward better quality of life (p = 0.06) at 1-year follow-up than did those with lesser regression.

Conclusions: In high-risk patients with severe aortic stenosis and severe LV hypertrophy undergoing TAVR, those with greater early LVM regression had one-half the rate of rehospitalization over the subsequent year compared to those with lesser regression.

Keywords: aortic stenosis; heart failure; hospitalizations; hypertrophic left ventricular remodeling; transcatheter aortic valve replacement.

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Conflict of interest statement

Conflicts of interest: Dr. Lindman is a site co-investigator for the PARTNER Trial. Dr. Pibarot has received an unrestricted research grant from Edwards Lifesciences. Dr. Devereux has received honoraria for training courses from Edwards Lifesciences, serves as a consultant for Merck, and serves on an advisory board of GE Medical. Dr. Sarano has received grant support from Abbott Vascular and consulting fees/honoraria from Valtech. Dr. Szeto has received consulting fees/honoraria from MicroInterventional Devices. Dr. Makkar has received grant support from Edwards Lifesciences and St. Jude Medical, is a consultant for Abbott Vascular, Cordis, and Medtronic, and holds equity in Entourage Medical. Dr. Miller has received travel reimbursements from Edwards Lifesciences related to his work as an unpaid member of the PARTNER Trial Executive Committee, and has received consulting fees/honoraria from Abbott Vascular, St. Jude Medical, and Medtronic. Dr. Lerakis has received consulting fees from Edwards Lifesciences. Dr. Bowers has received consulting fees/honoraria from Daiichi Sankyo/Eli Lilly and Edwards Lifesciences. Dr. Leon has received travel reimbursements from Edwards Lifesciences related to his activities as an unpaid member of the PARTNER Trial Executive Committee. Dr. Douglas has received institutional research support from Edwards Lifesciences. The other authors report no relevant relationships with industry.

Figures

Figure 1
Figure 1. Flow diagram for subjects included in the analysis
Abbreviations: TAVR, transcatheter aortic valve replacement; RCT, randomized controlled trial; NRCA, non-randomized continued access registry; LVMi, left ventricular mass index; LVH, left ventricular hypertrophy.
Figure 2
Figure 2. Regression of Left Ventricular Mass Index after Transcatheter Aortic Valve Replacement in Patients with Severe Left Ventricular Hypertrophy
Left ventricular mass index (LVMi) regression is shown for patients (combined, men, and women) who had severe LVH at baseline and survived at least 1 year after transcatheter aortic valve replacement (TAVR) (a). The pattern of change in LVMi over 1 year after TAVR is shown for patients with severe LVH at baseline who had greater vs. lesser change in LVMi from baseline to 30 days post-TAVR (based on sex-specific median % change in LVMi) (b). The mean LVMi from all available echoes at each time point is shown. *p<0.001. **p<0.05.
Figure 3
Figure 3. Time-to-event curves for death or repeat hospitalizations from 30 days to 1 year
Time-to-event curves are shown from 30 days to 1 year for a) death (all-cause), b) repeat hospitalizations, c) repeat hospitalizations for heart failure, and d) death (all-cause) or repeat hospitalizations for patients with symptomatic aortic stenosis and severe left ventricular hypertrophy at high surgical risk receiving transcatheter aortic valve replacement (TAVR) in the PARTNER randomized trial or continued access registry. The curves compare patients with greater vs. lesser left ventricular mass index (LVMi) regression from baseline to 30 days after TAVR (based on sex-specific median % change in LVMi). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank
Figure 3
Figure 3. Time-to-event curves for death or repeat hospitalizations from 30 days to 1 year
Time-to-event curves are shown from 30 days to 1 year for a) death (all-cause), b) repeat hospitalizations, c) repeat hospitalizations for heart failure, and d) death (all-cause) or repeat hospitalizations for patients with symptomatic aortic stenosis and severe left ventricular hypertrophy at high surgical risk receiving transcatheter aortic valve replacement (TAVR) in the PARTNER randomized trial or continued access registry. The curves compare patients with greater vs. lesser left ventricular mass index (LVMi) regression from baseline to 30 days after TAVR (based on sex-specific median % change in LVMi). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank
Figure 3
Figure 3. Time-to-event curves for death or repeat hospitalizations from 30 days to 1 year
Time-to-event curves are shown from 30 days to 1 year for a) death (all-cause), b) repeat hospitalizations, c) repeat hospitalizations for heart failure, and d) death (all-cause) or repeat hospitalizations for patients with symptomatic aortic stenosis and severe left ventricular hypertrophy at high surgical risk receiving transcatheter aortic valve replacement (TAVR) in the PARTNER randomized trial or continued access registry. The curves compare patients with greater vs. lesser left ventricular mass index (LVMi) regression from baseline to 30 days after TAVR (based on sex-specific median % change in LVMi). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank
Figure 3
Figure 3. Time-to-event curves for death or repeat hospitalizations from 30 days to 1 year
Time-to-event curves are shown from 30 days to 1 year for a) death (all-cause), b) repeat hospitalizations, c) repeat hospitalizations for heart failure, and d) death (all-cause) or repeat hospitalizations for patients with symptomatic aortic stenosis and severe left ventricular hypertrophy at high surgical risk receiving transcatheter aortic valve replacement (TAVR) in the PARTNER randomized trial or continued access registry. The curves compare patients with greater vs. lesser left ventricular mass index (LVMi) regression from baseline to 30 days after TAVR (based on sex-specific median % change in LVMi). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank
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