Impact of conscious sedation or general anesthesia on mitral valve function after percutaneous edge-to-edge reconstruction: a single cohort study

Abstract Background Percutaneous mitral valve transcatheter edge-to-edge repair (M-TEER) has emerged as a treatment option in patients with severe primary and secondary mitral regurgitation (MR) not considered suitable candidates for surgery. Currently, most procedures are performed under general anaesthesia (GA), while an increasing number of centres additionally perform the procedure under dexmedetomidine conscious sedation (DCS) in selected patients. Purpose To compare the functional outcome of M-TEER with the MitraClip or PASCAL P10/ACE Device – system in patients receiving the procedure under GA or DCS. Methods Consecutive patients scheduled for M-TEER procedures in DCS or GA were included in this retrospective study. Outcomes were compared using matching criteria (MR etiology, left ventricular ejection fraction, New York Heart Association functional class, Revised Cardiac Risk Index – Score, chronic obstructive pulmonary disease, body mass index, coronary heart disease and ASA preoperative physical status classification) to adjust for baseline differences. The primary endpoint included device effectiveness (Reduction of MR directly after the procedure and at hospital discharge) and procedure duration. The main safety endpoint was defined as a composite of all-cause death, stroke, cardiac-structural complication, cardiogenic shock, acute kidney injury requiring renal replacement therapy, moderate or severe bleeding according to the Mitral Valve Academic Research Consortium (MVARC). Results 37 patients in the DCS group and 60 patients in the GA group were analysed. Successful implantation of the M-TEER device was achieved in 98.9% of (96 of 97) patients. Device effectiveness was comparably high in both groups (100 % in DCS vs. 98.3% in GA; p=0.619) with significant shorter procedural duration favoring DCS DCS 84min (72-111) vs.GA 96min (75-137) (p=0.041). Total hospital length of stay (LOS) from the index procedure did not differ (DCS:4.8d (IQR) vs. GA:5.4d (IQR); p =0.344). The matching-analysis yielded comparable groups of 36 pairs. Fluoroscopy time (12 ± 6 minutes in the DCS group versus 15 ± 6 minutes in the GA group, P=0.130) and dose area product (9.97 (SD) Gy/cm2 in the GA group and 7.03 (SD) Gy/cm2 in the DCS group, P=0.066) were equally distributed in both cohorts (Figure 2). Moreover, device effectiveness was comparable in both groups at discharge (MR≤1:DCS 86.1% vs.GA 83.3%;p=0.743), with patients exhibiting mostly trivial MR in the DCS group (DCS 41.7% vs.GA 11.1%;p=0.027) (Figure 1). No difference between GA and DCS was observed with respect to the occurrence of the composite safety endpoint (p=0.155). There was no conversion to open surgery and no differences in postoperative complications between the two groups. Conclusions DCS is a feasible and safe option for M-TEER procedures with shorter procedural times compared to GA. No disadvantages with respect to procedural outcome or complications were observed.