Initial Experiences with the MitraClip G4: Review of the Novel Device Features

Abstract

Objective

Percutaneous edge-to-edge mitral valve repair is an evolving procedure with increasing indications for use. The MitraClip™ G4 is the newest device with 4 device options, each with distinct characteristics. While the NTR and XTR clips have been in use, the G4 adds 2 new wider clips with additional features, the NTW and XTW.

Methods

We reviewed 26 cases employing the MitraClip G4 at our institution from November 2019 to March 2020.

Results

The NTR, XTR, NTW, and XTW clips were used in 3 (11.5%), 0 (0.0%), 16 (61.5%), and 11 (42.3%) cases, respectively. Median mitral regurgitation grade was reduced from 4+ to 1+, though 7 (27%) cases had 2+ residual mitral regurgitation.

Conclusions

The new G4 device includes simplified instructions for use, the option of a wider clip, controlled gripper actuation, and potential left atrial pressure monitoring. The newest MitraClip G4 device allows for potential improved treatment options for patients with mitral regurgitation.

Keywords

mitral regurgitation percutaneous edge-to-edge mitral valve repair MitraClip controlled gripper actuation

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References

Baumgartner

Falk

Bax

et al. ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 2017; 2017: 2739–2791.

Nishimura

RA.

Otto

CM.

Bonow

et al. AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 2014: e57–e185.

Stone

GW.

Lindenfeld

Abraham

et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med 2018; 379: 2307–2318.30280640

Feldman

Foster

Glower

et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011; 364: 1395–1406.21463154

Feldman

Wasserman

HS.

Herrmann

et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol 2005; 46: 2134–2140.16325053

Glower

DD.

Kar

Trento

et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol 2014; 64: 172–181.25011722

Lim

DS.

Reynolds

MR.

Feldman

et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol 2014; 64: 182–192.24184254

Maisano

Franzen

Baldus

. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol 2013; 62: 1052–1061.23747789

Obadia

JF.

Messika-Zeitoun

Leurent

et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med 2018; 379: 2297–2306.30145927

10.

Abbott Vascular . MitraClip™ NTR/XTR Clip Delivery System [package insert]. Abbott Vascular website, https://eifu.abbottvascular.com/content/dam/av/eifu-us/EL2123342.pdf (2019, accessed 30 April 2020).

11.

Abbott Vascular . MitraClip™ G4 System [package insert]. Abbott Vascular website, https://eifu.abbottvascular.com/content/dam/av/eifu-us/EL2119397.pdf (2019, accessed 30 April 2020).

12.

Evalve, Inc . MitraClip^® Clip Delivery System [package insert]. U.S. Food and Drug Administration website, https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100009c.pdf (2013, accessed 8 March 2020).

13.

Abbott Vascular . MitraClip™ NT Clip Delivery System [package insert]. U.S. Food and Drug Administration website, https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100009S028D.pdf (2019, accessed 8 March 2020).

14.

Maisano

Schreuder

JJ.

Oppizzi

et al. The double-orifice technique as a standardized approach to treat mitral regurgitation due to severe myxomatous disease: surgical technique. Eur J Cardiothorac Surg 2000; 17: 201–205.10758376

15.

Lim

SD.

Rottbauer

Mahoney

et al. Contemporary outcomes with MitraClip™ (NTR/XTR) System in primary mitral regurgitation: results from the Global EXPAND Study. Paper presented at: ACC.20, Chicago, IL, USA, 30 March 2020.

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