Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve Repair in the U.S. A report from the STS/ACC TVT Registry ACC 2015 LBCT Paul Sorajja, MD, Saibal Kar, MD, Amanda Stebbins, Sreekanth Vemulapalli, MD, D. Scott Lim, MD, Vinod Thourani, MD, Michael Mack, MD, David R. Holmes, Jr., MD, Wesley A. Pedersen, MD, and Gorav Ailawadi, MD
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Outcomes of the Initial Experience with Commercial Transcatheter Mitral
Valve Repair in the U.S.
A report from the STS/ACC TVT Registry
ACC 2015 LBCT
Paul Sorajja, MD, Saibal Kar, MD, Amanda Stebbins, Sreekanth Vemulapalli, MD, D. Scott Lim, MD, Vinod Thourani, MD,
Michael Mack, MD, David R. Holmes, Jr., MD, Wesley A. Pedersen, MD, and Gorav Ailawadi, MD
Disclosures Paul Sorajja, MD Abbott Vascular, Medtronic, Lake Regions, Boston Scientific
David R. Holmes, Jr, MD Boston Scientific
Wesley A. Pedersen, MD Abbott Vascular, Intervalve, Lake Regions Medical, Medtronic
D. Scott Lim, MD Abbott Vascular, Edwards Lifesciences, Mitralign
Saibal Kar, MD Abbott Vascular, AGA Medical, Boston Scientific, Coherex Medical, Medtronic, St. Jude Medical
Michael Mack, MD Abbott Vascular, Edwards Lifesciences
Other Procedure Indications • Frailty……………........................................... • Hostile chest……………………..................... • Porcelain aorta………………….…………….. • RV dysfunction with severe TR….…....…… • Immobility………………………………....…… • Severe liver disease (MELD >12)…….......... • IMA at high risk of injury……………………. • Unusual extenuating circumstance…….…
• EVEREST I……………….. • EVEREST II RCT…...….… • EVEREST II HRS……......
71 67 76
74% 77% 86%
0.9% 1.1% 2.6%
79% 51% 30%
Conclusions
1) In this first report of the U.S. commercial experience with TMVR, procedure success, clinical outcomes, and adverse events were favorable in comparison to pre-approval studies and other national registries
2) These data demonstrate effectiveness and safety of TMVR with MitraClip for the treatment of prohibitive risk patients with symptomatic MR
0 1 3 2
• EDD (↑)
• Case volume (↑)
• A2-P2 implant
• Baseline MR (↑)
• Age (↑)
• Male gender
• ESD (↑)
• MAC
• Mitral gradient (↑)
• MVA <4 cm2
• > 1 clip placed
• FMR
p 0.12
0.17
0.07
0.03
• Severe TR
Odds Ratio for MR grade ≤2
0.29 0.03
0.01
0.12
0.90
0.33
0.23
0.43
0.01
Clinical Variables and Residual MR
0
10
20
30
40
50
60
0 5 10 15 20 25STS-PROM for mitral replacement
Surgical Risk and Cases 564 patients at 61 hospitals