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TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and.

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Presentation on theme: "TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and."— Presentation transcript:

1 TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and Michael J. Mack, MD on behalf of The PARTNER II Trial Investigators and The PARTNER Publications Office 1-Year Results from the PARTNER II Valve-in-Valve Registry

2 Background and Aims Valve-in-valve (VIV) TAVR has emerged as a viable alternative for patients with failing surgical bioprosthetic valves.Valve-in-valve (VIV) TAVR has emerged as a viable alternative for patients with failing surgical bioprosthetic valves. We sought to assess the safety and efficacy of VIV TAVR with the Edwards SAPIEN XT transcatheter heart valve (THV) in patients with failed surgical bioprosthetic valves at high risk with reoperation.We sought to assess the safety and efficacy of VIV TAVR with the Edwards SAPIEN XT transcatheter heart valve (THV) in patients with failed surgical bioprosthetic valves at high risk with reoperation.

3 Methods Inclusion criteria:Inclusion criteria: –Symptomatic severe stenosis or regurgitation of a surgical aortic tissue valve –High-risk for re-operation (estimated surgical mortality or major morbidity ≥ 50%) –Suitable for 23mm or 26mm SAPIEN XT THV Exclusion criteria:Exclusion criteria: –Surgical valve labeled size < 21mm –Prosthetic valve in another position Angiogram, CT, Echo images and clinical data were screened on a weekly web conference callAngiogram, CT, Echo images and clinical data were screened on a weekly web conference call

4 Analysis Population N = 197 Analysis Population N = 197 Study Population PARTNER 2 Valve-in-Valve Registry N = 99 At 24 sites between June 2012 and April 2013 PARTNER 2 Valve-in-Valve Registry N = 99 At 24 sites between June 2012 and April 2013 2 patients withdrew consent prior to procedure Primary Endpoint: 1 Year Mortality PARTNER 2 Valve-in-Valve Extended Registry N = 100 At 34 sites between May 2013 and December 2013 PARTNER 2 Valve-in-Valve Extended Registry N = 100 At 34 sites between May 2013 and December 2013

5 CharacteristicOverall (n = 197) Age - Years 78.5 ± 11.0 Male - % 60.4 STS Score 9.7 ± 5.1 NYHA Class III/IV - % 95.4 CAD - % 70.6 COPD (O 2 Dependent) - % 7.1 CKD (Cr ≥ 2mg/dL) - % 12.7 Atrial Fibrillation - % 49.7 Permanent Pacemaker - % 25.9 Frailty - % 33.0 Baseline Patient Characteristics Demographics All values expressed as % or Mean ± Standard DeviationVIVRegistry (n = 97) Extended VIV Registry (n = 100) p-value 80.1 ± 9.377.0 ± 12.30.05 55.765.00.18 9.8 ± 5.19.5 ± 5.10.64 95.995.00.22 68.073.00.45 5.29.00.29 14.411.00.47 50.549.00.83 27.824.00.54 37.129.00.23

6 Surgical Bioprosthesis Age % < 5 years < 5 years8.1 5-10 years 5-10 years32.4 > 10 years > 10 years59.5 Mode of Degeneration Stenosis Stenosis54.2 Regurgitation Regurgitation22.4 Mixed Mixed23.4 Surgical Valve Type Bioprosthetic Stented Bioprosthetic Stented94.4 Stentless/Homograft Stentless/Homograft4.6 Unknown Unknown1.0 Valve and Procedure Characteristics Labeled Surgical Valve Size % 21mm 21mm28.3 23-25mm 59.7 >25mm >25mm12.0 Implanted THV Size 23mm 23mm72 26mm 26mm28 Access Transfemoral67 Transapical33

7 1-Year All-Cause Mortality Mortality (%) No. at Risk All VIV Pts. 197181172169129 Months 13.4% at 1 Year All VIV Patients 4.1% at 30 Days

8 1-Year All-Cause Mortality Mortality (%) No. at Risk VIV Registry 9785807761 VIV Extended Registry 10096929268 Months 19.7% VIV Registry 7.2% VIV Extended Registry Overall Log-Rank p-value = 0.008 9.3% at 30 Days 0% at 30 Days

9 Clinical Outcomes 30 Days and 1 Year Complication 30 Days 1 Year All-Cause Mortality 8 (4.1) 26 (13.4) Cardiac Mortality Cardiac Mortality 7 (3.6) 17 (8.9) Stroke (All) 5 (2.5) 7 (3.7) Rehospitalization 14 (7.3) 22 (11.8) All values are expressed as n (%) and percentages are Kaplan-Meier estimates at 30 days or 1 year.

10 Functional Outcomes NYHA Class 197181 95.5 11.6 12.0 p = NS p < 0.0001 158No. Patients

11 Functional & Quality of Life Outcomes Mean [95% CI] No. Patients 191181136 p < 0.0001 p = 0.20 No. Patients 191176144 Six Minute Walk Test Distance KCCQ Overall Summary Score p = 0.0014 p < 0.0001

12 Echocardiographic Outcomes p = NS p = 0.02 No. of Evaluable Echos 175162117 Mean [95% CI] LV Ejection Fraction p < 0.0001 p = 0.0002 175162117 Mean [95% CI] LV Mass index

13 Clinical Implication Valve-in-Valve TAVR using SAPIEN XT is a beneficial therapeutic alternative to reoperation in patients with failed aortic bioprostheses.

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