Does implantation of a single clip provide reliable durability after transcatheter mitral repair?†

OBJECTIVES A single MitraClip implant is often considered enough to achieve adequate mitral regurgitation (MR) reduction. The aim of this study was to compare MR recurrence in patients with an initial optimal result treated with a single clip versus those treated with two clips. METHODS From October 2008 to May 2016, 322 patients were treated with the MitraClip procedure at our institution. We retrospectively selected all patients treated for functional MR (FMR) and degenerative MR (DMR) aetiologies with residual MR ≤1+, excluding patients who required >2 clips. FMR and DMR were analysed separately. RESULTS In FMR, a single clip was used in 45 patients and 2 clips in 99 patients. The single clip group had smaller coaptation depth (1.1 ± 0.3 vs 1.3 ± 0.3 mm, P  = 0.022) and jet extension (10.5 ± 2.1 vs 13.0 ± 3.6 mm, P  = 0.026) as well as left ventricular end-diastolic diameter (64.4 ± 7.3 vs 69.0 ± 7.9 mm, P  = 0.001). Freedom from MR ≥ 3+ after 4 years was 71.9 ± 8.9% in patients receiving a single clip vs 88.0 ± 5.2% in those receiving 2 clips, single clip use being an independent predictor of MR recurrence (HR 3.48, CI 1.24-9.81, P  = 0.018). In DMR, a single clip was deployed in 24 patients and 2 clips in 30 patients. The single clip group had a smaller flail gap (3.6 ± 0.7 vs 6.8 ± 2.5, P  = 0.002). Freedom from MR ≥ 3+ after 2 years was 82.5 ± 8% in patients with a single clip vs 100% in those with 2 clips, P  = 0.014. The residual mitral area was reduced in patients with 2 clips compared with those with single clip, both in FMR ( P  = 0.015) and DMR ( P  = 0.039), but it was not associated with increased death rate during the follow-up period (all P  > 0.05). CONCLUSIONS Despite favourable anatomical characteristics and an optimal initial result, implantation of a single clip was associated with an increased recurrence of MR compared with that of 2 clips, both in FMR and in DMR. Caution should be exercised with the implantation of a single clip.

[1]  R. Lange,et al.  Surgical mitral valve intervention following a failed MitraClip procedure. , 2016, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[2]  O. Alfieri,et al.  Optimal results immediately after MitraClip therapy or surgical edge-to-edge repair for functional mitral regurgitation: are they really stable at 4 years? , 2016, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[3]  O. Alfieri,et al.  Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. , 2016, European heart journal.

[4]  P. Boekstegers,et al.  One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry , 2015, European heart journal.

[5]  Antonio Colombo,et al.  The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement? , 2015, European heart journal.

[6]  D. Capodanno,et al.  Predictors of clinical outcomes after edge-to-edge percutaneous mitral valve repair. , 2015, American heart journal.

[7]  O. Alfieri,et al.  Long-Term Results (⩽18 Years) of the Edge-to-Edge Mitral Valve Repair Without Annuloplasty in Degenerative Mitral Regurgitation: Implications for the Percutaneous Approach , 2014, Circulation.

[8]  S. Blankenberg,et al.  Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry. , 2014, Journal of the American College of Cardiology.

[9]  Nancy M Albert,et al.  2014 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. , 2014, The Journal of thoracic and cardiovascular surgery.

[10]  J. Hausleiter,et al.  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. , 2013, Journal of the American College of Cardiology.

[11]  O. Alfieri,et al.  [Guidelines on the management of valvular heart disease (version 2012). The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)]. , 2013, Giornale italiano di cardiologia.

[12]  O. Alfieri,et al.  Guidelines on the management of valvular heart disease. , 2007, European heart journal.

[13]  Laura Mauri,et al.  The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. , 2010, American heart journal.

[14]  J. Zamorano,et al.  European Association of Echocardiography recommendations for the assessment of valvular regurgitation. Part 2: mitral and tricuspid regurgitation (native valve disease). , 2010, European journal of echocardiography : the journal of the Working Group on Echocardiography of the European Society of Cardiology.

[15]  O. Alfieri,et al.  Recurrence of mitral regurgitation parallels the absence of left ventricular reverse remodeling after mitral repair in advanced dilated cardiomyopathy. , 2008, The Annals of thoracic surgery.

[16]  D. C. Miller,et al.  Effect of Chronotropy and Inotropy on Stitch Tension in the Edge-to-Edge Mitral Repair , 2007, Circulation.

[17]  Jeroen J. Bax,et al.  Preoperative left ventricular dimensions predict reverse remodeling following restrictive mitral annuloplasty in ischemic mitral regurgitation. , 2005, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[18]  Trevor Hastie,et al.  Mitral annular size predicts Alfieri stitch tension in mitral edge-to-edge repair. , 2004, The Journal of heart valve disease.

[19]  R. Levine,et al.  Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. , 2003, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[20]  D. C. Miller,et al.  Edge-to-Edge Mitral Repair: Tension on the Approximating Suture and Leaflet Deformation During Acute Ischemic Mitral Regurgitation in the Ovine Heart , 2001, Circulation.