Transcatheter Mitral Valve Implantation (TMVI) Using Edwards SAPIEN 3 Prostheses in Patients at Very High or Prohibitive Surgical Risk: A Single-Center Experience

Table 3

Clinical outcome (in-hospital, 30-day-, 6-month- and one-year follow-up).

Patients treated: n = 7
In-hospital follow-up
Clinical success (with improvement in at least one NYHA functional class after procedure)	100% (7/7)
NYHA functional class post procedure
Improvement by two NYHA functional classes	29% (2/7)
Improvement by one NYHA functional class	71% (5/7)
No improvement in NYHA functional class	0% (0/7)
NYHA functional class after procedure
NYHA class IV	0% (0/7)
NYHA class III	29% (2/7)
NYHA class II	71% (5/7)
NYHA class I	0% (0/7)
Residual mitral regurgitation after TMVI at hospital discharge
None	29% (2/7)
Trace or mild (MR grade I)	57% (4/7)
Moderate (MR grade 2)	14% (1/7)
Severe (MR grade 3)	0% (0/7)
Complications
Vascular access site bleeding complication	0% (0/7)
Device embolization	0% (0/7)
Need for second valve implantation	0% (0/7)
Cardiac perforation/cardiac tamponade	0% (0/7)
Major stroke	0% (0/7)
New arrhythmia	14% (1/7)
Conversion to open heart surgery	0% (0/7)
Acute kidney injury	0% (0/7)
LVOT obstruction by implanted mitral valve prosthesis	0% (0/7)
Major atrial septal defect (ASD) after TMVI, hemodynamically relevant	43% (3/7)
Interventional ASD closure	29% (2/7)
Pacemaker implantation post TMVI	14% (1/7)
In-hospital mortality rate	14% (1/7)
In-hospital stay from TMVI to hospital discharge (days, mean ± SD)	12 ± 6.1
Clinical follow-up after hospital discharge
30-day mortality rate (all-cause)	14% (1/7)
6-month mortality rate (all-cause)	14% (1/7)
One-year mortality rate (all-cause, n = 6)	17% (1/6)
NYHA functional class at 30-day and 6-month follow-up (n = 6)
NYHA class IV	0% (0/6)
NYHA class III	17% (1/6)
NYHA class II	83% (5/6)
NYHA class I	0% (0/6)
NYHA functional class at 1-year follow-up (available in n = 5)
NYHA class IV	0% (0/5)
NYHA class III	20% (1/5)
NYHA class II	80% (4/5)
NYHA class I	0% (0/5)