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Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve Repair in the U.S.

This report analyzes the initial commercial experience of transcatheter mitral valve repair (CTVR) using the MitraClip System in the US. The study examines procedure success, complications, and device-related events, providing valuable insights for the medical industry.

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Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve Repair in the U.S.

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  1. ACC 2015 LBCT Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve Repair in the U.S. A report from the STS/ACC TVT Registry Paul Sorajja, MD, SaibalKar, MD, Amanda Stebbins, Sreekanth Vemulapalli, MD, D. Scott Lim, MD, VinodThourani, MD, Michael Mack, MD, David R. Holmes, Jr., MD, Wesley A. Pedersen, MD, and GoravAilawadi, MD

  2. Michael Mack, MD Abbott Vascular, Edwards Lifesciences Vinod Thourani, MD Abbott Vascular, Apica Cardiovascular , Boston Scientific, Edwards Lifesciences, Medtronic, Sorin, St. Jude Medical Saibal Kar, MD Abbott Vascular, AGA Medical, Boston Scientific, Coherex Medical, Medtronic, St. Jude Medical Disclosures David R. Holmes, Jr, MD Boston Scientific Gorav Ailawadi, MD Abbott Vascular, Atricure, Edwards Lifesciences, Mitraaling, St. Jude Paul Sorajja, MD Abbott Vascular, Medtronic, Lake Regions, Boston Scientific Wesley A. Pedersen, MD Abbott Vascular, Intervalve, Lake Regions Medical, Medtronic Sreekanth Vemulapalli, MD Abbott Vascular, Boston Scientific, Medtronic D. Scott Lim, MD Abbott Vascular, Edwards Lifesciences, Mitralign Amanda Stebbins, MS None

  3. Background • Surgery is the standard of care, and is indicated for patients with symptoms or LV dysfunction Degenerative MR is common, affecting ~600,000 persons in the U.S. • However, there are patients in whom the risk of surgery is prohibitive

  4. The MitraClip System Transcatheter Mitral Valve Repair • Commercial approval October 24, 2013 • Indicated for symptomatic patients with primary MR ≥3 and prohibitive surgical risk

  5. TMVR with MitraClip in the U.S. Over 100 sites activated Outcomes of commercial experience unknown

  6. Study Objective To analyze and report the initial commercial experience of TMVR with the MitraClip System in the U.S.

  7. Transcatheter Mitral Valve Repair STS/ACC TVT Registry • Collaboration of STS, ACC, CMS, hospitals, medical industry • Patient-level data with DCRI as analytic center • Participation satisfies NCD* *patients may not reflect all procedures during this study period

  8. All commercial TMVR cases with MitraClip enrolled in TVT registry through August 31, 2014 were identified (n=564) Methods • Examined in-hospital and 30-day outcomes for procedure success, complications, and device-related events.

  9. Procedure success Post-implant MR grade ≤2, without CV surgery and without in-hospital mortality Outcome Definitions • Procedure complications cardiac perforation, major bleeding, stroke, MI, mitral injury, or death • Device-related adverse events Single leaflet device attachment, complete clip detachment, device thrombosis, device or delivery component embolization

  10. 564 patients at 61 hospitals Surgical Risk and Cases No. Cases

  11. Median age (% men)…………………..….. • NYHA III/IV……………………………….………. • HF hospitalization prior yr…………….…….... • Atrial fibrillation………………………….……... • Prior CVA………………………………….……… • Diabetes………………………………….………. • Prior CABG……………………………….……… • Prior MI…………………………………………... • Creatinine ≥2 g/dl………………………………. • O2-dependency………………………….……… • Median STS-PROM MV repair..............… • Median STS-PROM MV replacement.…. 83 yrs (56%) 83.9% 51.8% 62.6% 8.7% 25.0% 32.4% 24.6% 16.7% 14.7% 7.9% (4.7, 12.2) 10.0% (6.3, 14.5) Study Population564 Patients

  12. Frailty……………........................................... 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…….… 57.2% 6.0% 3.4% 2.3% 1.2% 0.5% 1.4% 25.3% Other Procedure Indications

  13. LV ejection fraction..………..…..…. • MR severity grade 3 or 4……….…. • LV EDD……………………………….. • LV ESD……………………………….. • Degenerative MR…………............... • Posterior prolapse.……………… • Posterior flail………………...…… • Functional MR………………............ • Mitral annular calcification…….…. • Leaflet calcification…….…………... • Mitral gradient ≥5 mmHg…………... • MVA <4 cm2………………………….. • Severe TR……………………………. 56% (45, 63%) 94.0% 5.2 cm (4.6, 5.8 cm) 3.6 cm (3.0, 4.5 cm) 85.5% 28.9% 28.0% 14.4% 38.4% 17.2% 8.0% 19.7% 14.7% Echocardiographic data

  14. Clip implantation occurred in 94% Change in Mitral Regurgitation 93% MR ≤2 Grade 2 Grade 4 63.7% MR≤1 Grade 1 p<0.001 Grade 3 Mitral Regurgitation

  15. Clinical Outcomes • Procedure success…. • Complications............ • Length-of-stay............ • Home discharge......... 91.8% 7.8% 3 d (1,6 d) 81.9%

  16. In-hospital mortality……………..……. • 30-day mortality………………………… • Cardiac surgery…….....………….……. • Stroke……………………………..……… • Myocardial infarction……………...…… • Major bleeding………………….….…… • Cardiac perforation……………….…… • Device-related events……………..…... • Single leaflet device attachment.... • Device embolization…………..…… • Other…………………………….….… 2.3% 5.8% 0.5% 1.8% 0% 3.9% 0.7% 2.7% 1.1% 0.4% 1.2% Adverse Events

  17. Clinical Variables and Residual MR Univariate Odds Ratios for MR grade ≤2 p=0.03 • EDD  p=0.03 • Baseline MR  • A2-P2 clip site p=0.01  • Case vol. (per 2) p=0.01  0 1 2 3 Odds Ratios Less MR More MR

  18. Prohibitive risk population with 86% DMR Commercial TMVR with MitraClip Data Summary • 91.8% procedure success • Device-related adverse events: 2.7% • Mortality: 2.3% in-hospital, 5.8% at 30-days • Procedure complications: 7.8% • EDD, MR, volume, clip site related to success

  19. In-hospital death Age (yrs) DMR MR ≤2 • STS/ACC TVT (US)...……. • SENTINEL (EU)….……….. • ACCESS (EU)….……...…. • TRAMI (DE)………..……… • MitraSwiss (CH)................ • France (FR)……................ • GRASP (IT)……..….…….… • Netherlands (NL)………… • MARS (Asia)……………… 83 74 74 75 77 73 72 73 71 86% 28% 23% 29% 38% 23% 24% 18% 46% 93% 95% 91% 95% 85% 88% 100% 93% 94% 2.3% 2.9% 2.9% 4.0% 3.3% 4.2% U.S. vs. Other Registries • EVEREST I……………….. • EVEREST II RCT…...….… • EVEREST II HRS……...... 71 67 76 79% 51% 30% 74% 77% 86% 0.9% 1.1% 2.6%

  20. 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 Conclusions 2) These data demonstrate effectiveness and safety of TMVR with MitraClip for the treatment of prohibitive risk patients with symptomatic MR

  21. Clinical Variables and Residual MR p 0.12 • Age (↑) • Male gender 0.17 • FMR 0.07 • EDD (↑) 0.03 • ESD (↑) 0.29 0.03 • Baseline MR (↑) • A2-P2 implant 0.01 • > 1 clip placed 0.12 • MAC 0.90 • Mitral gradient (↑) 0.33 • MVA <4 cm2 0.23 • Severe TR 0.43 • Case volume (↑) 0.01 0 2 1 3 Odds Ratio for MR grade ≤2

  22. 564 patients at 61 hospitals Surgical Risk and Cases No. Cases

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