title: Influence of experience on procedure steps, safety, and functional results in edge to edge mitral valve repair-a single center study.
abstract: OBJECTIVE
  We sought to determine the effects of experience on the Mitraclip®procedure steps as well as procedure safety and functional results.
  
  
  BACKGROUND
  MR has proven deleterious in heart failure. Mitraclip®therapy evolved an important option in patients with severely reduced left ventricular function (LVEF).
  
  
  METHODS
  Between 2011 and 2016, 126 consecutive patients were grouped in three groups and investigated in a prospective observational study. We evaluated the duration of procedural steps, safety endpoints, and functional results.
  
  
  RESULTS
  The median logistic EuroScore was 32% (7-40%). Ninety-five percent of patients were in NYHA-stage ≥III and 51% had a LVEF <30%. Groups were homogeneous as to their baseline NYHA status and right heart catheterization data. Echocardiography data are comparable, albeit with a decreasing effective regurgitant orifice area (0.44 ± 0.21 group I vs. 0.34 ± 0.22 group III, P = 0.02). Frailty was less frequent and baseline 6 min walking test results improved from group I to group III. Duration of a first clip placement decreased from 106 ± 50 to 50 ± 21 min (P < 0.001). Total procedure time decreased from 221 ± 70 to 144 ± 68 (P < 0.001). The number of clips implanted increased from 66 to 79 (P = 0.02). MitraClip®implantation was effective in either group but the combined safety endpoint was reached less frequent in group III (P = 0.01). There was no difference in MACCE rate, 30 day- or intrahospital-mortality between groups.
  
  
  CONCLUSIONS
  Safety and duration of procedure steps improved substantially with experience. MR reduction was sustained from the beginning without further improvement. Patient selection is a key factor for success. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany.
authors.forename: Karsten
authors.identifier: http://orcid.org/0000-0001-5808-5842
authors.initials: K
authors.lastname: Hamm
authors.affiliation: Department of Cardiac Surgery, Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Zacher
authors.affiliation: Department of Cardiology, Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Hautmann
authors.affiliation: Department of Cardiology, Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Gietzen
authors.affiliation: Department of Cardiology, Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Halbfass
authors.affiliation: Department of Cardiology, Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kerber
authors.affiliation: Department of Cardiac Surgery, Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany.
authors.forename: Anno
authors.initials: A
authors.lastname: Diegeler
authors.affiliation: Department of Cardiology, Phillipp University of Marburg, Marburg, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Schieffer
authors.affiliation: Department of Cardiology, Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Barth
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D002983:Clinical Competence; D004452:Echocardiography; D017079:Exercise Tolerance; D005260:Female; D005858:Germany; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D059032:Learning Curve; D016015:Logistic Models; D008297:Male; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology*; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D020127:Recovery of Function; D012307:Risk Factors; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D000070857:Walk Test
keywords: Mitraclip®; edge to edge repair; experience; heart failure; mitral regurgitation