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ACC 2015 Jae K. Oh, MD On Behalf of the US CoreValve Investigators Remodeling of Self-Expanding Transcatheter Aortic Valve Is Responsible for Regression.

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Presentation on theme: "ACC 2015 Jae K. Oh, MD On Behalf of the US CoreValve Investigators Remodeling of Self-Expanding Transcatheter Aortic Valve Is Responsible for Regression."— Presentation transcript:

1 ACC 2015 Jae K. Oh, MD On 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

2 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. 2

3 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 3

4 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 PVAR 2.To perform detailed serial hemodynamic analyses of forward cardiac output and aortic bioprosthesis Hypothesis and Aims 4

5 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 5

6 ACC 2015 Determination of PVAR Severity by Integrating Multiple Parameters <10% (<36°) 10 – 20% (36-72°) >20% (>72°) VARC-1 Mild Moderate Severe 6

7 ACC 2015 RESULTS 7

8 Characteristic, % or mean ± SD TAVR N=634 Age (years) 82.7 ± 8.4 Men 47.3 STS Predicted Risk of Mortality (%) 10.4 ± 5.6 NYHA class III/IV91.8 Body surface area (m 2 ) 1.8 ± 0.3 Creatinine >2 mg/dL 4.1 Baseline Demographics 8

9 ACC 2015 Percentage of Echo Exams with Total Aortic Regurgitation and PVAR at Discharge 9

10 ACC 2015 PVAR Paired Comparison at Discharge and 1 Year 10

11 ACC 2015 1 Year DischargeNone (N=123) Trivial (N=143) Mild (N=102) Moderate (N=14) Severe (N=1) None4918710 Trivial50483420 Mild23664260 Moderate1111851 Severe00100 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 11 PVAR at Discharge and 1 Year

12 ACC 2015 Impact of PVAR on All-Cause Mortality Landmark Analysis None/Trace 296280254233 Mild 216206173157 Moderate 49473837 Severe 7311 No. at Risk 0-1 M1-6 M6-12 M All-Cause Mortality (%) Months Post Procedure 12

13 ACC 2015 Annulus Sizing Ratio Valve Perimeter – Annulus Perimeter Annulus Perimeter X 100 13 Annual Sizing Ratio (%)

14 ACC 2015 Acute Improvement of AV Hemodynamics TAVR with CoreValve Mean ± SD (#)BaselineDischarge* 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 (cm 2 ) 0.73 ± 0.24 (518) 1.78 ± 0.51 (509) * P <0.0001 for all parameters 14

15 ACC 2015 Stroke Volume Changes after TAVR 15 Error bars represent standard deviation

16 ACC 2015 Further Improvement in AV Hemodynamics At 1 Month Mean ± SD (#)BaselineDischarge1 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 (cm 2 ) 0.73 ± 0.24 (518) 1.78 ± 0.51 (509) 1.85 ± 0.58 ** (500) 16 *P <0.0001 **P=0.03

17 ACC 2015 Continuous Reduction in AV Gradient 17

18 ACC 2015 AV Velocity and EOA 18 * ** ***

19 ACC 2015 LVOT Diameter Outer to Outer Edge 19

20 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 20

21 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. 21 Conclusion

22 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

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