NeoChord Mitral Valve Repair. Department of Cardiac, Thoracic and Vascular Sciences University of Padua, Italy
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1 NeoChord Mitral Valve Repair Department of Cardiac, Thoracic and Vascular Sciences University of Padua, Italy
2 Disclosures Proctoring for Neochord Inc.
3 NeoChord procedure Transapical off-pump mitral valve repair with neochordae implantation (TOP-MINI), also know as NeoChord Repair, is a novel transcatheter ECHO-GUIDED procedure to treat patient suffering severe symptomatic Degenerative MR
4 NeoChord MV Repair Biosimulator Training
5 Double Lumen tube paddles NeoChord Repair Operative Setting TEE probe Full monitoring Safety net Cell Saver right side rotation CVC line
6 NeoChord Repair Skin incision Lateral 5th Intercostal space
7 NeoChord Repair Finger Test for Identification of Ventricular Access before opening pericardium
8 NeoChord Repair Finger Test for Identification of Ventricular Access
9 NeoChord Repair 2 circumferencial ventricular purse strings
10 NeoChord Repair Siemens Dual View entry site verification
11 NeoChord Repair Safety net in the groin
12 NeoChord Repair Ventriculotomy and Orientation
13 NeoChord Repair Device Insertion
14 NeoChord Repair Ventricular Navigation on 2D-TEE
15 NeoChord Repair Ventricular Navigation on 2D-TEE
16 NeoChord Repair First NeoChord Implantation
17 NeoChord Repair Second NeoChord Implantation
18 NeoChord Repair Third NeoChord Implantation
19 NeoChord Repair Fourth NeoChord Implantation
20 NeoChord Repair Manual tensioning
21 NeoChord Repair NeoChords are passed through a teflon pledget
22 NeoChord Repair The teflon pledget is stabilized to the epicardial surface
23 NeoChord Repair Final Tensioning with tourniquets
24 NeoChord Repair Final Fine Over-Tensioning
25 NeoChord Repair Final Fine Over-Tensioning
26 NeoChord Repair Neochord Fixation
27 NeoChord Repair Neochord Final result
28 NeoChord Repair Neochord Fixation
29 Surgical Indications Degenerative Mitral Valve Disease (leaflet flail or prolapse) Are all patients good for NeoChord Repair? Are there specific anatomical features to consider for patient selection? Is there an absolute number for annular dilatation?
30 Preoperative 2D and 3D-TEE 1. Mechanism of MV disease (leaflet flail or prolapse) 2. MV Anatomical type definition: Type A: Isolated P2 prolapse/flail Type B: Multisegment prolapse/flail (P1-P2; P2- P3; P1-P2-P3) Type C: Anterior Prolapse/flail Type D: Paracommissural disease Annular and leaflet calcifications 3. Quantification of leaflet overlapping (Leaflet-to-Annulus Index) 4. Quantification of Coaptation Index
31 Preoperative TEE MV Anatomical type definition TYPE A
32 Preoperative TEE MV Anatomical type definition TYPE B
33 Preoperative TEE MV Anatomical type definition TYPE C
34 Preoperative TEE MV Anatomical type definition TYPE D
35 Preoperative echocardiographic assessment Leaflet-to-Annulus Index (LAI): an echocardiographic predictor of outcomes PML AP AML LAI= PML+ AML AP Colli et al, ACC 2016 Colli et al, IJC 2018
36 Preoperative echocardiographic assessment Leaflet-to-Annulus Index (LAI): an echocardiographic predictor of outcomes When LAI is 1.21 the sum of the leaflets length is at least 21% longer than AP annular dimension A LAI cut-off value of 1.21 was identified as a positive pre-operative predictor of MR mild at 1-year follow-up This excess of leaflet tissue will constitute the potential coaptation surface after NeoChord MVr Colli et al, IJC 2018
37 Preoperative echocardiographic assessment Off-line Postprocessing (TomTec)
38 Preoperative echocardiographic assessment Off-line Postprocessing: LAI calculation 1 AML 35mm 2 PML 27mm 3 AP 46mm AML 35mm 2 PML 27mm 3 AP 46mm LAI=
39 Preoperative echocardiographic assessment Coaptation Index PML AP Coaptation Index = AML PML + AML- AP 2 Yoshida et al Circ J, 2017 Colli et al, submitted
40 1 AML 35mm 2 PML 27mm 3 AP 46mm Preoperative echocardiographic assessment Off-line Rielaboration: Coaptation Index AML 35mm 2 PML 27mm 3 AP 46mm Coaptation Index = 8mm 2 3 1
41 PRE-OPERATIVE CT-SCAN RIELABORATION 3mensio MV suite AML LEFT ATRIUM PML
42 MV ANNULUS PRE-OPERATIVE CT-SCAN RIELABORATION MV Annulus Segmentation
43 PRE-OPERATIVE CT-SCAN RIELABORATION Leaflet-to-Annulus Index CT based LAI MEASUREMENTS
44 PRE-OPERATIVE CT-SCAN RIELABORATION Access Site and Coronary artery Identification LAD DIAG PL-CX
45 Ideal Ventricular access site Colli et al, JACC Imaging 2017
46 Postoperative Ventricular access site Colli et al, JACC Imaging 2017
47 Postoperative NeoChord Colli et al, JACC Imaging 2017
48 Postoperative NeoChord Colli et al, JACC Imaging, 2017
49 Ventricular access sites for Transapical NeoChord Repair Colli et al, JACC Imaging 2017
50 Patient-Specific ventricular access site selection based on LAI Colli et al, ATS 2017
51 NeoChord Padova Experience 168 patients consecutive patients and 1 months in year in years in 82 3-years in 21 patients Colli et al, Circulation in press
52 Methods Outcomes were defined according to MVARC guidelines Primary endpoint was defined as PATIENT SUCCESS composite of: - Procedure success = placement of at least 2 Neochordae and residual MR mild at the end of the procedure - Freedom from Major Adverse Events (MAE) = death, stroke, MR > moderate, structural or functional failure and/or Reoperation - Decrease in NYHA functional classification ( 1 class)
53 Methods MR severity was graded as: Absent (0) Mild (1+) : VC<3mm, pulmonary vein flow=systolic dominance, RV<30ml Moderate (2+): VC=3-6mm, pulmonary vein flow=systolic blunting, RV<31-59ml Severe (3+): VC>7mm, systolic flow reversal, RV 60ml
54 Baseline Caractheristics Median (I-III Quartile ) or N (%) Age (years) 64 (54 74) Male 130 (77,4%) Euroscore-II (%) 1 (0,6-1,8) STS-PROM MV repair score (%) 0,6 (0,3-1,6) Arterial hypertension 96 (57,1%) COPD 17 (10,1%) Diabetes mellitus type II 11 (6,6%) Associated ischemic cardiomyopathy 27 (16,1%) Previous Cardiac Surgery 9 (5,4%) Previous PCI 16 (9,5%) Recent or Active Malignancy 18 (10,7%) Glomerular filtration rate (ml/min) 74,6 (55,3-90,7)
55 Baseline Caractheristics NYHA functional class - I - II - III - IV MR grade - Absent/trace - Mild - Moderate - Severe N (%) 41 (24,4%) 58 (34,5%) 63 (37,5%) 6 (3,6%) 0 (0%) 0 (0%) 0 (0%) 168 (100%)
56 Baseline Caractheristics Leaflet Prolapse Leaflet flail PML disease AML disease Bileaflet disease Anatomic MV Type - A - B - C - D N (%) 71 (42,3%) 97 (57,7%) 153 (91,1%) 7 (4,2%) 8 (4,7%) 76 (45,3%) 65 (38,7%) 15 (8,9%) 12 (7,1%)
57 Baseline Caractheristics EF (%) > 55 iedv (ml/m 2 ) - < > 100 Median (I-III Quartile) 63 (58-67) 0 (0%) 34 (20,2%) 134 (79,8%) 82 (72-93) 34 (20,2%) 113 (67,3%) 21 (12,5%) spap (mmhg) > 45 TR - Absent - Mild - Moderate Median (I-III Quartile) 33 (25-42) 47 (28,0%) 53 (31,9%) 30 (17,9%) 34 (20,2%) 52 (31%) 88 (52,4%) 28 (16,6%)
58 Operative Characteristics Median (I-III Quartile) or N (%) Neochordae in place (n) (3-4) 4 (2,4%) 46 (27,4%) 76 (45,2%) 27 (16,1%) 9 (5,4%) 2 (1,2%) 3 (1,8%) 1 (0,5%) Operative time (min) 120 ( ) Intraop Blood Cell saved (ml) 560 ( ) Conversion to conventional surgery - MV Repair - MV Replacement 3 (1,8%) 1 (0,6%) 2 (1,2%) Procedure success 165 (98,2%)
59 Operative Outcomes Median (I-III Quartile) or N (%) Mechanical ventilation time (hours) 2 (1-3) - 0.R. extubation 36 (21,8%) (59,4%) (12,1%) - > 6 11 (6,7%) Hospital stay (days) 7 (6-8) Discharge - Home 123 (75,0%) - Rehabilitation center 40 (24,4%) - In hospital death 1 (0,6%) IMA 1 (0,6%) Transient ischemic attack 1 (0,6%) Stroke 0 (0%)
60 Operative Outcomes Median (I-III Quartile) or N (%) Procedural ECMO support 4 (2,4%) Procedural IABP support 1 (0,6%) Access site complications 2 (2,0%) Bleeding - Minor (<2BU) - Major (2-4BU) - Extensive (>4BU or plasma or platelets) Pericardial effusion - Minor - Major 17 (10%) 9 (5,4%) 3 (1,8%) 5 (3,0%) 12 (7,3%) 0 (0%)
61 Operative Outcomes Median (I-III Quartile) or N (%) Acute kidney Injury 6 (3,5%) Conduction disturbances - Transient - Permanent - Need of PPM implantation New onset atrial fibrillation - Paroxysmal - Persistent Pleural effusion - Minor - Major 2 (1,2%) 0 (0%) 0 (0%) 41 (24,9%) 9 (5,5%) 77 (46,7%) 4 (2,4%)
62 Overall Patient Success
63 Patient Success by Morphology
64 Mitral Regurgitation Overall
65 Mitral Regurgitation for Type A MR Moderat e 97%
66 Mitral Regurgitation for Type B MR Moderat e 97%
67 Mitral Regurgitation for Type C MR Moderat e 86%
68 Mitral Regurgitation for Type D MR Moderate 83%
69 Echocardiographic Outcomes Overall population
70 Example of Immediate changes in MV geometry in after the NeoChord procedure
71 Example of Immediate changes in MV geometry in after the NeoChord procedure Colli et al, IJC 2018
72 Example of Immediate changes in MV geometry in after the NeoChord procedure Colli et al, IJC 2018
73 Acute Echocardiographic changes Pre Value Median (I-III I quartile) Post-Value Median (I-III quartile) Median of Differences (Δ) Median (I-III quartile) Δ% p Value Systolic AP Diameter (mm) 33.8 ( ) 30.8 ( ) 2.1 ( ) 6.3 <0.001 TAPSE (mm) 26.5 ( ) 19.7 ( ) 6.7 ( ) spap (mmhg) 35 ( ) 29 ( ) 1 ( ) ilav (ml/m 2 ) 47.6 ( ) 46.6 ( ) 5.5 (0-15.7) ilvesv (ml/m 2 ) 28.3 ( ) 28.2 ( ) -0.3 (-4-5.1) ilvedv (ml/m 2 ) 75.5 ( ) 66.3 ( ) 11.7 ( ) 10.9 <0.001 LVEF (%) 62 (58-67) 57 (54-61) 3.5 ( ) 6.2 <0.001
74 Acute TomTec Echocardiographic changes Pre Value Median (I-III quartile) Post-Value Median (I-III quartile) Median of Differences (Δ) Median (I-III quartile) Δ% p Value AP Diameter (mm) 34 ( ) 31 ( ) 0.2 ( ) 6.9 <0.001 LL Diameter (mm) 39.4 ( ) 39.1 ( ) ( ) Sphericity Index 0.85 ( ) 0.77 ( ) 0.07 ( ) 7.9 <0.001 Annulus Circumference (mm) 12.6 ( ) 11.9 ( ) 10 ( ) Annulus Area (mm 2 ) 11.6 ( ) 10.3 ( ) 2.6 ( ) Tenting Height (mm) 3.5 ( ) 10.6 ( ) -7 (-9.8;-3.2) <0.001 AAo-AP Angle ( ) ( ) 1.4 ( ) -0.11(-0.18;-0.04)
75 Correlation between Acute AP diameter reduction and MR grades of reduction at 1-year Grades of MR reduction at 1Y FU AP diameter acute reduction (mm)
76 Key Messages Patient Selection and Timing of intervention are paramount for Valve interventions Pre-Procedural Leaflet-to-Annulus Index and Coaptation Index are essentials tools for case planning and procedural success The NeoChord Ringless procedure presents good clinical and echocardiographic results in patients with «Type A and B» lesions up o 2- years
77 Key Messages If the LAI and Coaptation Index are not adeguate to provide enough surface of coaptation for isolated Neochord Ringless leaflet therapy a MV Annuloplasty device should be added to increase surface of copatation Mainz-Padua Universities Transcatheter MV COMBO Therapies Proof-of-Concept EHJ in Press
78 COMBO MV Therapies Annuloplasty + Leaflet Therapy CARILLON Mitral Contour System Edwards CardioBand Neochord repair Amend Valcare Mainz-Padua Universities Transcatheter MV COMBO Therapies Proof-of-Concept EHJ 2018
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