Transcatheter Mitral Valve Replacement in High-Surgical Risk Patients: A Single-Center Experience and Outcome

Table 2

Preprocedural, procedural, and postprocedural safety and quality measures for the studied patients.

Procedural characteristics	TMVR total N: 64	Groups			value
		TMViV N: 35 (55%)	TMViR N: 16 (25%)	TMViMAC N: 13 (20%)
Pre-procedural data for preparation
Prior MV bioprosthesis types
Carpentier–Edwards (Edwards Lifesciences)		21 (60.0%)
Mosaic® ULTRA™ (Medtronic)		7 (20.0%)
Epic™ (St. Jude medical)		5 (14.3%)
Hancock™ II (Medtronic)		2 (5.7%)
Prior MV ring types
Edwards Lifesciences			6 (37.5%)
Medtronic			4 (25.0%)
St Jude Medical			4 (25.0%)
Procedural data
Anesthesia
General anesthesia	46 (71.9%)	23 (65.7%)	12 (75.0%)	11 (84.6%)	0.411
Conscious sedation	18 (28.1%)	12 (34.3%)	4 (25.0%)	2 (15.4%)
Pre-TMVR balloon dilatation	10 (15.6%)	1 (2.9%)	2 (12.5%)	7 (53.9%)	<0.001
Pre-TMVR balloon size (mm)	25.6 ± 2.4	22.0 ± 0.0	23.5 ± 2.1	26.7 ± 1.6	0.039
Post-TMVR distal valve flaring	64 (100.0%)	35 (100.0%)	16 (100.0%)	13 (100.0%)
Valve type (Edward SAPIEN-3)	64 (100.0%)	35 (100.0%)	16 (100.0%)	13 (100.0%)
Valve size (mm)					0.003
23	7 (10.9%)	2 (5.7%)	5 (31.3%)	0 (0.0%)
26	33 (51.6%)	18 (51.4%)	9 (56.3%)	6 (46.2%)
29	24 (37.5%)	15 (42.9%)	2 (12.5%)	7 (53.9%)
Concomitant procedures
Concomitant PCI	9 (14.1%)	3 (8.6%)	2 (12.5%)	4 (30.8%)	0.142
Concomitant TAVI	9 (14.1%)	7 (20.0%)	0 (0.0%)	2 (15.4%)	0.161
Procedure status
Elective	54 (84.4%)	32 (91.4%)	13 (81.3%)	9 (69.2%)	0.071
Urgent	6 (9.4%)	2 (5.7%)	2 (12.5%)	2 (15.4%)
Emergency/salvage	4 (6.3%)	1 (2.9%)	1 (6.3%)	2 (15.4%)
Mechanical assist devices (CBP)	6 (9.4%)	1 (2.9%)	2 (12.5%)	3 (23.1%)	0.153
Procedural time (minutes)	58.7 ± 8.9	58.9 ± 9.2	58.1 ± 7.0	59.2 ± 10.5	0.941
Fluoroscopy time (minutes)	41.1 ± 8.2	41.1 ± 8.9	40.6 ± 6.6	41.7 ± 8.4	0.940
Technical success	62 (96.9%)	35 (100.0%)	15 (93.8%)	12 (92.3)	0.711
Procedural complications
Access site complications	7 (10.9%)	2 (5.7%)	2 (12.5%)	3 (23.1%)	0.225
Significant blood loss/blood transfusion	6 (9.4%)	2 (5.7%)	2 (12.5%)	2 (15.4%)	0.525
CHB/new pacemaker	3 (4.7%)	1 (2.9%)	0 (0.0%)	2 (15.4%)	0.017
Valve malposition/embolization/thrombosis	2 (3.1%)	0 (0.0%)	1 (6.3%)	1 (7.7%)	0.091
MV reintervention/surgery	1 (1.6%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0.136
Procedural mortality	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	–
In-hospital outcome
Timing of extubation (days)	0.5 ± 0.2	0.4 ± 0.1	0.5 ± 0.3	0.5 ± 0.5	0.056
ICU stay (days)	1.3 ± 0.5	1.3 ± 0.6	1.3 ± 0.5	1.5 ± 0.5	0.273
Total in-hospital stay (days)	3.2 ± 1.3	3.3 ± 1.4	2.9 ± 1.1	3.6 ± 1.5	0.324
In-hospital complications
Pleural effusion	7 (10.9%)	3 (8.6%)	2 (12.5%)	2 (15.4%)	0.225
CHB/PPM	4 (6.3%)	2 (5.7%)	1 (6.3%)	1 (7.7%)	0.525
Pneumonia	2 (3.1%)	2 (5.7%)	0 (0.0%)	0 (0.0%)	0.425
Stroke	1 (1.7%)	0 (0.0%)	0 (0.0%)	1 (7.7%)	0.136
Valve malposition/migration/embolization/thrombosis	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	–
MV reintervention/surgery	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	–
Mortality	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	–
3-month complications and outcome
Valve thrombosis	2 (3.1%)	0 (0.0%)	1 (6.3%)	1 (7.7%)	0.185
Paravalvular leak	1 (1.6%)	0 (0.0%)	1 (6.3%)	0 (0.0%)	0.277
Hospitalization for HF	3 (4.7%)	0 (0.0%)	2 (12.5%)	1 (7.7%)	0.043
MV reintervention/surgery	1 (1.6%)	0 (0.0%)	1 (6.3%)	0 (0.0%)	0.277
Mortality	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	–
6-month complications and outcome
Valve degeneration	3 (4.7%)	0 (0.0%)	1 (6.3%)	2 (15.4%)	0.035
Hospitalization for HF	3 (4.7%)	0 (0.0%)	1 (6.3%)	2 (15.4%)	0.035
MV reintervention/surgery	3 (4.7%)	0 (0.0%)	1 (6.3%)	2 (15.4%)	0.035
Mortality	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	–
Periprocedural antithrombotic therapy
DAPT (aspirin-clopidogrel or aspirin-ticagrelor)	29 (45.3%)	16 (45.7%)	9 (56.3%)	4 (30.8%)	0.115
Anticoagulant and antiplatelet	35 (54.7%)	19 (54.3%)	7 (43.8%)	9 (69.2%)	0.070

CBP: cardiopulmonary bypass, CHB: complete heart block, DAPT: dual antiplatelet therapy, HF: heart failure, ICU: intensive care unit, MV: mitral valve, PCI: percutaneous coronary intervention, PPM: permanent pacemaker, TAVI: transcatheter aortic valve implantation, TMVR: transcatheter mitral valve replacement, TMViV: transcatheter mitral valve-in-valve, TMViR: transcatheter mitral valve-in-ring, TMViMAC: transcatheter mitral valve-in-mitral annular calcification, TTVR: transcatheter tricuspid valve replacement.