title: Optimal results immediately after MitraClip therapy or surgical edge-to-edge repair for functional mitral regurgitation: are they really stable at 4 years?
abstract: OBJECTIVE
  Recurrent mitral regurgitation (MR) is common after surgical and percutaneous (MitraClip) treatment of functional MR (FMR). However, the Everest II trial suggested that, in patients with secondary MR and initially successful MitraClip therapy, the results were sustained at 4 years and were comparable with surgery in terms of late efficacy. The aim of this study was to assess whether both those findings were confirmed by our own experience.
  
  
  METHODS
  We reviewed 143 patients who had an initial optimal result (residual MR ≤ 1+ at discharge) after MitraClip therapy (85 patients) or surgical edge-to-edge (EE) repair (58 patients) for severe secondary MR (mean ejection fraction 28 ± 8.5%). Patients with MR ≥ 2+ at hospital discharge were excluded. The two groups were comparable. Only age and logistic EuroSCORE were higher in the MitraClip group.
  
  
  RESULTS
  Follow-up was 100% complete (median 3.2 years; interquartile range 1.8;6.1). Freedom from cardiac death at 4 years (81 ± 5.2 vs 84 ± 4.6%, P = 0.5) was similar in the surgical and MitraClip group. The initial optimal MitraClip results did not remain stable. At 1 year, 32.5% of the patients had developed MR ≥ 2+ (P = 0.0001 compared with discharge). Afterwards, patients with an echocardiographic follow-up at 2 years (60 patients), 3 years (40 patients) and 4 years (21 patients) showed a significant increase in the severity of MR compared with the corresponding 1 year grade (all P < 0.01). Freedom from MR ≥ 3+ at 4 years was 75 ± 7.6% in the MitraClip group and 94 ± 3.3% in the surgical one (P = 0.04). Freedom from MR ≥ 2+ at 4 years was 37 ± 7.2 vs 82 ± 5.2%, respectively (P = 0.0001). Cox regression analysis identified the use of MitraClip as a predictor of recurrence of MR ≥ 2+ [hazard ratio (HR) 5.2, 95% confidence interval (CI) 2.5-10.8, P = 0.0001] as well as of MR ≥ 3 (HR 3.5, 95% CI 0.9-13.1, P = 0.05).
  
  
  CONCLUSIONS
  In patients with FMR and optimal mitral competence after MitraClip implantation, the recurrence of significant MR at 4 years is not uncommon. This study does not confirm previous observations reported in the Everest II randomized controlled trial indicating that, if the MitraClip therapy was initially successful, the results were sustained at 4 years. When compared with the surgical EE combined with annuloplasty, MitraClip therapy provides lower efficacy at 4 years.
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy michele.debonis@hsr.it.
authors.forename: Michele
authors.initials: M
authors.lastname: De Bonis
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Lapenna
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Buzzatti
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: La Canna
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Denti
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Pappalardo
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Schiavi
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Pozzoli
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Micaela
authors.initials: M
authors.lastname: Cioni
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Di Giannuario
authors.affiliation: Department of Cardiac Surgery, IRCCS San Raffaele Hospital, Vita e Salute San Raffaele University, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation / Q000379:methods; D008943:Mitral Valve / Q000503:physiopathology / Q000601:surgery; D058386:Mitral Valve Annuloplasty / Q000379:methods; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D011379:Prognosis; D019736:Prostheses and Implants; D012008:Recurrence; D012720:Severity of Illness Index; D016019:Survival Analysis; D016896:Treatment Outcome
keywords: MitraClip; Mitral valve repair; Percutaneous mitral repair; Secondary mitral regurgitation