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Nappi et al. Vessel Plus 2021;5:40  https://dx.doi.org/10.20517/2574-1209.2021.06                                                                                       Page 5 of 20


                              Table 1. Baseline characteristics of all patients in transcatheter approach group [1,15,23,24,26,31]

                                                                                                                                                           Age, y,      STS      NYHA Class      LVEF (%; mean ±
                                                                                                                    Overall TMViV TMViR TMVIMAC
                                                                                                                                                           median       score    III or IV       SD)

                              US Registry                                                                           349      266      83                   76           11.1
                              Brigham and Women’s Hospital                                                          520      prev     prev                 63.3 ± 13.5  6.12 ±   319             60
                                                                                                                             MVR      MVP                               6.52

                                                                                                                             273      247
                              TMVR Registry                                                                         248      176      72                   72.5 ± 12.1  8.9 ± 6.8 221            52.5 ± 13.9
                              Mayo Clinic, NY University Medical Centre, Intermounitain Heart Institute, University of   87  60       15       12          75 ± 11      13 ± 8   87              57 ± 11
                              Alabama, St. Michael’s Hospital, Centre Cardiologique du Nord
                              Multicentre Published reports (2009-2018)                                             245      172      73                   73 ± 12.1    15.6 ±   98.2            46.7 ± 14.1
                                                                                                                                                                        13.5
                              Flinders Medical Centre (Adelaide) (2017-2018)                                        7        7                             82           4.34     5               > 60% (5); 30%-
                                                                                                                                                                                                 45% (2)
                              St. Paul’s Hospital (Vancouver, Canada)                                               23       23                            81.1 ± 5.8   12.6 ±   22              54.5 ± 12.3
                                                                                                                                                                        6.9

                              TMViV: Transcatheter mitral valve-in-valve; TMViR: transcatheter mitral valve-in-ring; STS: Society of Thoracic Surgeons; NYHA: New York Heart Association; LVEF: left ventricle ejection fraction; TMVR:
                              transcatheter mitral valve replacement; TMVIMAC: transchateter mitral valve in mitral annular calcification; MVR: mitral valve repair; MVP: mitral valve replacement.



                              TMViV (6.9% vs. 2.3%; P = 0.07), respectively. The concern related to life-threatening or fatal bleeding more frequently affected TMViR recipients (8.3%

                              TMViR vs. 2.3% TMViV; P = 0.03), while reoperation was necessary for 25 patients (10.1%), more frequently in the TMViR arm than in the TMViV one
                              (16.7% vs. 7.4%; P = 0.03)  [18,26] .


                              The survival benefits of TMViV-T in a small number of patients with failed bioprosthetic mitral valves were proved in a report by Nappi et al.  and
                                                                                                                                                                                                           [32]
                              Webb et al.  nearly 10 years ago. TMViV-T was used for 24 high-risk patients with degenerated valves bioprostheses (aortic, n = 10; mitral, n = 7; pulmonary,
                                          [33]
                              n = 6; or tricuspid, n = 1). The first-in-human use of a percutaneous transseptal approach was unsuccessful. On the contrary, five subsequent patients were
                              managed successfully with the use of transapical access for TMViV implantations. The procedure was relatively easily accomplished; all patients not only

                              survived at 30-day follow-up, but there was no mortality at a median 72-day follow-up             [16,18,19,28] .


                              TMViR has been used since 2010 in a restricted number of patients (n = 17) who had failed annuloplasty rings, demonstrating how promising this safe and

                              efficacious approach is for this type of mechanical intervention. The survival rate survival was 82% (14/17 patients) at 30 days, while, at the most recent follow-
                              up (13 ± 5 months), the percentage of surviving patients dropped to 71% (12/17) .
                                                                                                                         [34]
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