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When Does Baseline Left Ventricular Function Influence
Survival Post Transcatheter Aortic Valve Implantation?
—The CoreValve Australia New Zealand Study —
Sanjeevan Pasupati, Waikato Hospital, Hamilton, New Zealand
Anthony Walton, Epworth and the Alfred Hospitals, Melbourne, Australia
Darren Walters, Prince Charles Hospital, Brisbane, Australia
Stephen Worthley, Royal Adelaide Hospital, Adelaide, Australia
John Ormiston, Mercy Hospital, Auckland, New Zealand
Robert Whitbourn, St. Vincent’s Hospital – Melbourne, Australia
Gerald Yong, Royal Perth Hospital, Perth, Australia
David Muller, St. Vincent’s Hospital – Sydney, Australia
Ian T. Meredith, MonashHeart, Monash University Melbourne, Australia
UC201400513 EE
Potential Conflicts of Interest
Speaker's name: Sanjeevan Pasupati
 I have the following potential conflicts of interest to report:
Consultant: Edwards Lifesciences, Medtronic, Inc., St. Jude Medical
Medtronic is the sponsor of the CoreValve Australia-New Zealand Study and
provided all statistical analyses and assisted in the graphical display of the data.
Background
 The influence of left ventricular (LV) function on the outcomes following
transcatheter aortic valve implantation (TAVI) is poorly understood.
 Limited data have demonstrated that regardless of baseline LV function, 1year survival is the same for surgical AV replacement and TAVI.1
 Despite initial favourable outcomes after TAVI, a considerable proportion
of patients die within the first 2 years.
 We assessed the effect of LV function and the aortic gradient generated
by it on the long-term outcomes post TAVI from the ongoing CoreValve
Australia and New Zealand Study.
1Ewe
SH, et al. Am Heart J. 160:6: 1113-1120.
CoreValve Australia-New Zealand Study
Study Design
 Prospective, observational study enrolling patients at 10 centres in Australia
and New Zealand
 Heart Team approach to screen eligible patients
 Patients enrolled from August 2008 to October 2012 were included in this
analysis
 Study enrollment ongoing
 100% data monitoring
 Independent Clinical Events Committee adjudicated all major adverse events
 Assessments at baseline, procedure, discharge and 1, 6, 12 & 24 months
* As of June 29, 2012. Enrollment ongoing.
CoreValve Australia-New Zealand Study
Baseline Characteristics
All 4 Groups
*P< 0.05 compared to NEF/HG
CoreValve Australia-New Zealand Study
30-day Outcomes
All 4 Groups
*P< 0.05 compared to NEF/HG
Echo parameters were available in 70-75% patients in each group
CoreValve Australia-New Zealand Study
LV Improvement
Baseline Characteristics
CoreValve Australia-New Zealand Study
Results - The Effect of LV Function
 Patients with low EF regardless of baseline AV gradient all died of
cardiovascular causes.
 Reduced LV function significantly impacted cardiovascular survival at 1 and
2 years.
 An absolute increase in EF ≥5% at 1 month occurred in 59% of patients
with LEF/LG, and 80% of patients with LEF/HG.
 2 years survival (89% vs. 72%) was significantly higher in patients who had
a clinically meaningful improvement in LV function 1 month post TAVI.
 Prior myocardial infarction was more common in patients with low EF and
in patients who showed no improvement or reduction in LV function post
TAVI.
CoreValve Australia-New Zealand Study
Results – The Effect of AV Gradient
 Preserved LV function (EF >50%) and high AV gradient (>40
mmHg) was associated with significantly better all-cause survival
(78% vs. 66%, p=0.02) and cardiovascular survival (86% vs. 66%,
p=0.001) compared with patients with reduced LV function (EF ≤
50%) and low AV gradient (≤40 mmHg).
 Patients with preserved LV function and low AV gradient
(paradoxical low gradient) had significantly better cardiovascular
survival than patients with low EF and low gradient at 12 months
(p= 0.04), but this was not present at 2 years (p= 0.179).
 Patients with paradoxical low gradient and preserved LV function
had reduced survival (although not significantly different) from
those patients with high AV gradient regardless of LV function.
CoreValve Australia-New Zealand Study
Limitations
 Retrospective
 Did not collect dobutamine stress information or pre
balloon aortic valvuplasty response, if done prior to
TAVI
 No core echocardiography laboratory
 A multi-variable analysis has not been performed to
look at predictors of long-term survival.
CoreValve Australia-New Zealand Study
Conclusions
 Patients with LEF and LG have worse outcomes post TAVI
especially if LV function fails to improve post procedure.
Balloon aortic valvuloplasty pre TAVI to demonstrate LVEF
improvement may be useful to deliver a more cost effective
therapy.
 Patients with LEF and HG showed sustained improvement in
EF with excellent survival and should proceed to TAVI if
indicated.
 The paradoxical low gradient preserved LV function, severe
aortic stenosis patients showed reasonable mid-term benefit
and should not be denied TAVI.
CoreValve Australia-New Zealand Study