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MitraClip

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MitraClip
Chest radiograph showing two MitraClips projecting over the heart.
Specialtycardiology

MitraClip (mitral clip) is a medical device used to treat mitral valve regurgitation for individuals who should not have open-heart surgery. It is implanted via a transcatheter technique and involves suturing together the anterior and posterior mitral valve leaflets.[1]

Medical use

MitraClip is used for patients with severe secondary mitral valve regurgitation that is refractory to medical therapy. Primary mitral regurgitation is usually due to an organic cause whereas secondary mitral regurgitation is due to a secondary ischemia or cardiomyopathy[2]. Open-heart surgery remains the preferred treatment option when possible for primary mitral regurgitation, due to the effectiveness and long-term record of the procedure in reducing mitral valve regurgitation.[1] Secondary Mitral regurgitation however can have different options in management as surgery has not been proven in clinical trials to be superior[2]


Advantages

Contraindications

Certain causes of mitral regurgitation, notably rheumatic fever, can be considered contraindications to having the procedure.

Adverse effects and complications

The most common complication of transcatheter mitral valve repair is access site bleeding, although transfusion is generally required less often than with surgical mitral valve repair. Rare but serious complications can include infective endocarditis, mitral stenosis, and device embolization. In general, major adverse events in a 30-day post-procedural time period are significantly lower with a transcatheter versus surgical approach.

History

In 1996, Ottavio Alfieri proposed to Dr Mehmet Oz that the mitral valve only needed one suture to close a leak. Oz developed the idea to use a catheter to put one staple in and submitted the patent for MitraClip in 1997.[3] He helped to create a start-up called Evalve Inc. in 1999, which later became a division of Abbott Laboratories.[4] The company's first chief executive officer was Ferolyn Powell. She grew Evalve Inc. until the Abbott acquisition in 2009, and led a trial of 600 patients that revealed those using MitraClip reduced their hospitalizations in half and deaths by 38 percent.[5]

MitraClip was first implanted in 2003, obtained CE marking in Europe in 2008, and approved by the U.S. Food and Drug Administration in 2013.[6] The FDA obligated the company to run post-marketing studies to confirm the safety and efficacy of the device.[7] Two industry-funded RCTs of the MitraClip in patients with mitral regurgitation and heart failure demonstrated mixed results.[2][8][9]

Abbott expanded its MitraClip training process in 2016, after several instances of surgical complications.[10]

References

  1. ^ a b Wan B, Rahnavardi M, Tian DH, Phan K, Munkholm-Larsen S, Bannon PG, Yan TD (November 2013). "A meta-analysis of MitraClip system versus surgery for treatment to severe mitral regurgitation". Ann Cardiothorac Surg. 2 (6): 683–692. doi:10.3978/j.issn.2225-319X.2013.11.02. PMC 3857006. PMID 24349969.
  2. ^ a b c Nishimura, Rick A.; Bonow, Robert O. (2018). "Percutaneous Repair of Secondary Mitral Regurgitation — A Tale of Two Trials". New England Journal of Medicine. 379 (24): 2374–2376. doi:10.1056/NEJMe1812279. ISSN 0028-4793. PMID 30575469.
  3. ^ Copelan, Christine (26 September 2018). "How Dr. Oz Kick-Started a Groundbreaking Device for Patients with Heart Failure". Parade.
  4. ^ "The MitraClip Story". Abbott Laboratories. June 23, 2016. Retrieved December 15, 2018.
  5. ^ Armstrong, Madeleine (23 March 2015). "MitraClip pioneer Ferolyn Powell dies in motorbike accident". Clinica.
  6. ^ Feldman T (March 2014). "Rollout of the MitraClip". Latest in Cardiology. American College of Cardiology.
  7. ^ "Approval letter for P100009" (PDF). FDA. October 24, 2013.
  8. ^ Obadia, Jean-François; Messika-Zeitoun, David; Leurent, Guillaume; Iung, Bernard; Bonnet, Guillaume; Piriou, Nicolas; Lefèvre, Thierry; Piot, Christophe; Rouleau, Frédéric; Carrié, Didier; Nejjari, Mohammed; Ohlmann, Patrick; Leclercq, Florence; Saint Etienne, Christophe; Teiger, Emmanuel; Leroux, Lionel; Karam, Nicole; Michel, Nicolas; Gilard, Martine; Donal, Erwan; Trochu, Jean-Noël; Cormier, Bertrand; Armoiry, Xavier; Boutitie, Florent; Maucort-Boulch, Delphine; Barnel, Cécile; Samson, Géraldine; Guerin, Patrice; Vahanian, Alec; Mewton, Nathan (2018). "Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation". New England Journal of Medicine. 379 (24): 2297–2306. doi:10.1056/NEJMoa1805374. ISSN 0028-4793. PMID 30145927.
  9. ^ Stone, Gregg W.; Lindenfeld, JoAnn; Abraham, William T.; Kar, Saibal; Lim, D. Scott; Mishell, Jacob M.; Whisenant, Brian; Grayburn, Paul A.; Rinaldi, Michael; Kapadia, Samir R.; Rajagopal, Vivek; Sarembock, Ian J.; Brieke, Andreas; Marx, Steven O.; Cohen, David J.; Weissman, Neil J.; Mack, Michael J. (2018). "Transcatheter Mitral-Valve Repair in Patients with Heart Failure". New England Journal of Medicine. 379 (24): 2307–2318. doi:10.1056/NEJMoa1806640. ISSN 0028-4793. PMID 30280640.
  10. ^ Rubenfire A, Rice S (March 2016). "MitraClip recall shines spotlight on surgeon training, testing concerns". Modern Healthcare.


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