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transcatheter mitral valve repair; transcatheter mitral edge-to-edge repair (TEER)

Indications: - secondary mitral regurgitation in patients with NYHA heart failure class III or IV [8] * transcatheter mitral valve repair improves survival in high surgical risk patients with severe mitral regurgitation [2] * 5-year advantage over medical care for patients with moderate-severe mitral regurgitation [9] Procedure: - MitraClip, a transcatheter system for mitral valve repair in patients with high surgical risk [8] - MitraClip device FDA-approved 2013 for patients with heart failure [3] - transcatheter edge-to-edge repair (TEER) with MitraClip for patients with heart failure & secondary mitral regurgitation [5] - similar 5 year outcomes to surgery in patients with severe mitral regurgitation (5 year survival 40%) [10] - 1,100 reports of patient deaths [11] * MitraClip system (illustration) [11] Complications: - transcatheter mitral valve repair - mortality: 2.7% in-hospital, 5% at 30 days, 26% at 1 year [4] - rehospitalization within 1-year for heart failure in 20% [4] Notes: - increasing use of transcatheter mitral valve repair vs surgical repair after approval of MitraClip (Abbott) in 2013, surpassing surgical repair in 2018 [7]

Related

transcatheter mitral valve replacement/insertion (TMVR, TMVI)

General

mitral valve repair transcatheter insertion of device

References

  1. Lindenfeld J, Abraham WT, Grayburn PA et al. Association of effective regurgitation orifice area to left ventricular end-diastolic volume ratio with transcatheter mitral valve repair outcomes: A secondary analysis of the COAPT trial. JAMA Cardiol 2021 Feb 3; [e-pub]. PMID: 33533873 https://jamanetwork.com/journals/jamacardiology/article-abstract/2775801 - Gillam LD. Reconciling COAPT and Mitra-FR results based on mitral regurgitation severity and left ventricular size: It's not so simple. JAMA Cardiol 2021 Feb 3; PMID: 33533877 https://jamanetwork.com/journals/jamacardiology/article-abstract/2775799
  2. Swaans MJ et al. Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients. JACC Cardiovasc Interv 2014 Aug; 7:875. PMID: 25147032 - Bonow RO. The saga continues: Does mitral valve repair improve survival in secondary mitral regurgitation? JACC Cardiovasc Interv 2014 Aug; 7:882 PMID: 25147033
  3. FDA News Release. March 14, 2019 FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633479.htm
  4. Sorajja PSorajja P, Vemulapalli S, Feldman T et al. Outcomes with transcatheter mitral valve repair in the United States: An STS/ACC TVT registry report. J Am Coll Cardiol 2017 Nov 7; 70:2315. (http://dx.doi.org/10.1016/j.jacc.2017.09.015 PMID: 29096801 - Bolling SF. First TMVR enters U.S. market as a therapy, and a gateway. J Am Coll Cardiol 2017 Nov 7; 70:2328 PMID: 29096802
  5. Mack MJ, Lindenfeld J, Abraham WT et al. 3-year outcomes of transcatheter mitral valve repair in patients with heart failure. J Am Coll Cardiol 2021 Mar 2; 77:1029. PMID: 33632476 https://www.sciencedirect.com/science/article/abs/pii/S0735109720382656 - Depta JP, Bhatt DL. Crossover in COAPT: Does this extend the reach of TMVr for treating functional MR? J Am Coll Cardiol 2021 Mar 2; 77:1041 PMID: 33632477 https://www.sciencedirect.com/science/article/abs/pii/S0735109721000036
  6. Davidson LJ, Davidson CJ Transcatheter Treatment of Valvular Heart Disease. A Review. JAMA. 2021;325(24):2480-2494 PMID: 34156404 https://jamanetwork.com/journals/jama/fullarticle/2781245
  7. Young MN, Kearing S, Albaghdadi MA et al Trends in Transcatheter vs Surgical Mitral Valve Repair Among Medicare Beneficiaries, 2012 to 2019. JAMA Cardiol. 2022. May 4. PMID: 35507335 https://jamanetwork.com/journals/jamacardiology/fullarticle/2791890
  8. Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022
  9. Stone GW et al. Five-year follow-up after transcatheter repair of secondary mitral regurgitation. N Engl J Med 2023 Mar 5; [e-pub] PMID: 36876756 https://www.nejm.org/doi/10.1056/NEJMoa2300213
  10. Kortlandt F, Velu J, Schurer R et al. Survival after MitraClip treatment compared to surgical and conservative treatment for high-surgical-risk patients with mitral regurgitation. Circ Cardiovasc Interv 2018 Jun; 11:e005985. PMID: 29895598 https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.117.005985 - Sorajja P, Gossl M. Waiting to exhale: Transcatheter repair of mitral regurgitation and survival. Circ Cardiovasc Interv 2018 Jun; 11:e006749. PMID: 29895604 https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.118.006749
  11. Hilzenrath D, Hacker KK When Medical Devices Malfunction. From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA. KFF Health News. 2024. July 9. https://kffhealthnews.org/news/article/mitraclip-heart-valve-device-dr-oz-fda/