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ACC 2015
Jae K. Oh, MDOn Behalf of the US CoreValve Investigators
Remodeling of Self-Expanding Transcatheter Aortic Valve Is Responsible for Regression of Paravalvular Aortic Regurgitation: An Observation from CoreValve US Pivotal Trial
CoreValve US Pivotal Trial
ACC 2015
Consulting for Medtronic, Inc.
Presenter Disclosure Information
Medtronic personnel performed all statistical analyses and assisted in the graphical display of the data presented.
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ACC 2015
• Transcatheter aortic valve replacement (TAVR) has become an effective therapy for patients with severe aortic stenosis deemed extreme and high risk for surgical AVR.
• Despite its therapeutic and technical success, paravalvular aortic prosthetic regurgitation (PVAR) is one of the major complications after TAVR.
• However, PVAR was found to regress over time in patients who underwent TAVR with the CoreValve which has a self-expanding Nitinol frame.
Background
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ACC 2015
Hypothesis: Outward remodeling of the aortic annulus by continuous self-expansion of the CoreValve bioprosthesis reduces the severity of PVAR
Aims: 1. To assess the prevalence and the natural history of
PVAR2. To perform detailed serial hemodynamic analyses of
forward cardiac output and aortic bioprosthesis
Hypothesis and Aims
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ACC 2015
• All implanted patients with severe AS in the CoreValve US Pivotal Extreme Risk Trial were studied (from 41 US sites)
• Annular sizing ratio with CoreValve perimeter using CT of aortic annulus perimeter
• Echocardiography at baseline, discharge, 1, 6, and 12 months analyzed by the Echo Core Lab at Mayo Clinic according to ASE/VARC 1 criteria
Methods
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ACC 2015Determination of PVAR Severityby Integrating Multiple Parameters
<10%(<36°)
10 – 20%(36-72°)
>20%(>72°)VARC-1
Mild Moderate Severe
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ACC 2015
RESULTS
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ACC 2015
Characteristic, % or mean ± SDTAVR
N=634Age (years) 82.7 ± 8.4Men 47.3STS Predicted Risk of Mortality (%) 10.4 ± 5.6NYHA class III/IV 91.8Body surface area (m2) 1.8 ± 0.3 Creatinine >2 mg/dL 4.1
Baseline Demographics
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ACC 2015Percentage of Echo Exams with Total Aortic Regurgitation and PVAR at Discharge
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ACC 2015PVAR Paired Comparison at Discharge and 1 Year
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ACC 2015
1 YearDischarge None
(N=123)Trivial
(N=143)Mild
(N=102)Moderate
(N=14)Severe(N=1)
None 49 18 7 1 0Trivial 50 48 34 2 0Mild 23 66 42 6 0Moderate 1 11 18 5 1Severe 0 0 1 0 0
Of 137 mild PVAR patients at discharge, 89 (65%) had none/trivial at 1 yr Of 36 moderate PVAR at discharge, 30 (83%) had <moderate at 1 yr
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PVAR at Discharge and 1 Year
ACC 2015Impact of PVAR on All-Cause MortalityLandmark Analysis
None/Trace 296 280 254 233
Mild 216 206 173 157
Moderate 49 47 38 37
Severe 7 3 1 1
No. at Risk
0-1 M 1-6 M 6-12 M
All-C
ause
Mor
talit
y (%
)
Months Post Procedure
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ACC 2015Annulus Sizing RatioValve Perimeter – Annulus Perimeter Annulus Perimeter X 100
13
Annu
al S
izin
g Ra
tio (%
)
ACC 2015Acute Improvement of AV HemodynamicsTAVR with CoreValve
Mean ± SD (#) Baseline Discharge*
AV peak velocity (m/s) 4.33 ± 0.67 (624)
2.08 ± 0.45 (578)
AV mean gradient (mm Hg) 47.81 ± 15.20 (624)
9.67 ± 4.44 (577)
Effective orifice area (cm2) 0.73 ± 0.24 (518)
1.78 ± 0.51 (509)
* P <0.0001 for all parameters 14
ACC 2015Stroke Volume Changes after TAVR
15Error bars represent standard deviation
ACC 2015Further Improvement in AV HemodynamicsAt 1 Month
Mean ± SD (#) Baseline Discharge 1 Month
Heart rate (bpm) 70.1 ± 13.0 (632)
74.2 ± 12.4 (593)
71.0 ± 12.8 (559)
LVOT velocity time integral (cm) 21.66 ± 5.58 (572)
20.86 ± 4.96 (552)
21.06 ± 5.24 (532)
AV peak velocity (m/s) 4.33 ± 0.67 (624)
2.08 ± 0.45 (578)
1.99 ± 0.46 * (543)
AV velocity time integral (cm) 104.45 ± 22.27 (624)
39.06 ± 9.86 (577)
39.37 ± 11.27 (544)
AV mean gradient (mm Hg) 47.81 ± 15.20 (624)
9.67 ± 4.44 (577)
8.93 ± 4.62 * (544)
Effective orifice area (cm2) 0.73 ± 0.24 (518)
1.78 ± 0.51 (509)
1.85 ± 0.58 ** (500)
16*P <0.0001 **P=0.03
ACC 2015Continuous Reduction in AV Gradient
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ACC 2015AV Velocity and EOA
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*
*****
ACC 2015LVOT DiameterOuter to Outer Edge
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ACC 2015
1. PVAR ≥ moderate severity occurred in 9.4% of patients after TAVR; however 83% of these patients experienced a decreased in severity by at least 1 grade at 1-year follow-up.
2. The annular sizing ratio in patients with none to trivial PVAR at 1 year was significantly higher than that of patients with > mild PVAR at 1 year.
3. In addition to acute improvement at discharge, AV velocity, mean gradient, and EOA further improved significantly at 1 month and were sustained up to 1 year, suggesting continuous self-expansion of the CoreValve.
Summary
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ACC 2015
Paravalvular aortic regurgitation was common after TAVR with CoreValve, but only severe PVAR was associated with
increased mortality. There was regression of mild to moderate PVAR. This regression is possibly related to
optimal oversizing of the bioprosthesis and continuous outward expansion of the CoreValve with Nitinol frame.
Further confirmation with serial CT or 3D echocardiography is needed.
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Conclusion
ACC 2015
Thank You !
Jae K. Oh, MD; Stephen H. Little, MD; Sahar M.
Abdelmoneim, MD; Michael J. Reardon, MD; Neal S.
Kleiman, MD; Grace Lin, MD; David Bach, MD; Linda
Gillam, MD; Biswajit Kar, MD; Joseph Coselli, MD; Partho
P. Sengupta, MD; Kanny Grewal, MD; James Chang, MD;
Yanping Chang, MS; Mike Boulware, PhD; David H. Adams,
MD; Jeffrey J. Popma, MD
for the CoreValve US Pivotal Trial Clinical Investigators