transapical off-pump mitral valve repair with neochordae

Transapical off-pump mitral

valve repair with neochordae

implantation: clinical and

echocardiographic outcomes

Andrea Colli, Laura Besola, Eleonora Bizzotto, Fabio

Zucchetta, Erica Manzan, Roberto Bellu, Dario Gregori,

Demetrio Pittarello, Gino Gerosa

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy

DISCLOSURES

Andrea Colli, Gino Gerosa, Erica Manzan, Fabio Zucchetta, Demetrio Pittarelloreceived travel grants from Neochord Inc.

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy

Transapical Off-Pump Mitral Valve Interventionwith Neochord Implantation (TOP-MINI)

Skin incision: left-lateral mini-thoracotomy at 5-6th intercostal space Transapical access No Cardiopulmonary bypass Delivery system: Neochord DS-1000 Real-Time TEE guidance Final fixation of Neochords (ePTFE, GoreTexTM) on the epicardium

Neochord DS-1000

Department of Cardiac, Vascular and Thoracic Sciences,

University of Padua

Preoperative Echocardiography


University of Padua

Preoperative 2D-TEE assessment

Preoperative Echocardiography


University of Padua

Preoperative 3D-TEE assessment

Patient preparation

in the OR

TOP-MINI

paddlesTEE probe

tubeCVC line

Full monitoring

Safety net

Preoperative assessment of valve stuctures

TOP-MINI

Left antero-lateral mini-thoracotomy

TOP-MINI


University of Padua

Finger Test

TOP-MINI


University of Padua

Apical purse strings


University of Padua

TOP-MINI

Transapical puncture


University of Padua

TOP-MINI

Transapical device insertion


University of Padua

TOP-MINI

Intraventricular navigation on 2D-TEE


University of Padua

TOP-MINI

Atrial navigation on 3D-TEE

Leaflet Grasping on 3D-TEE

TOP-MINI


University of Padua

Leaflet Grasping and Neochord deployment

TOP-MINI


University of Padua

Device retrieval after neochord deployment

TOP-MINI

Department of Cardiac, Vascular and

Thoracic Sciences, University of Padua


University of Padua

Formation of half-hitch knot on the leaflet after chord deployment

TOP-MINI

Department of Cardiac, Vascular and

Thoracic Sciences, University of Padua


University of Padua

Neochord manual tensioning


University of Padua

TOP-MINI

Neochord passed into a round apical teflon pledget

TOP-MINI


University of Padua Department of Cardiac, Vascular and Thoracic Sciences,

University of Padua

Anchoring of the NeoChords on the epicardium


University of Padua

TOP-MINI

Final assessment of MV function with 2D-TEE

TOP-MINI

Dept. Cardiac, Vascular and Thoracic Sciences, University of Padua, Cardiac Surgery Unit


University of Padua

Final assessment of MV function with 3D-TEE

TOP-MINI


University of Padua

After wound closure


University of Padua

TOP-MINI


University of Padua

TOP-MINI

• Between November 2013-March 2015

61 patients were treated

• 31 patients completed the 6 months follow-up

• All symptomatic patients in NYHA III/IV

• TTE and clinical follow-up at 1-3-6 months

Variable Median (I-III quartile) or n (%)

Age (years) 73,5 (57-78) Male Gender (n) 21 (66%) Logistic EuroScore I (%) 5,2 (0,9-8.2) EuroScore II (%) 1,8 (0,7-2.75) STS score (%) 1,6 (0,5-2.2) Arterial Hypertension 26 (81,2%) Chronic Obstructive Pulmonary Disease 3 (9,4%) Diabetes mellitus type II 3 (9,4%) Associated Ischemic Cardiomyopathy 6 (18,8%) Reintervention 3 (9,4%) Prior percutaneous coronary intervention 3 (9,4%) Prior stroke 0Malignacy 3 (9,4%) Renal function (GFR) (ml/min) 72,7 (26,7-167,4) NYHA functional class

IIIIIIV

11 (34,4%) 18 (56,2%)

3 (9,4%)

PATIENTS BASELINE CHARACTERISTICS

Variables Median (I-III quartile) or n (%)

Leaflet involvementPosterior Mitral Leaflet (PML)Anterior Mitral Leaflet (AML)AML and PML

28 (87,5%) 3 (9,4%) 1 (3,1%)

Left Ventricle Ejection Fraction> 55%30-55%

26 (81,3%) 6 (18,7%)

Left Ventricle End Diastolic Volume< 70 mL/m2

70-100 mL/m2

> 100 mL/m2

9 (28,1%) 18 (56,3%) 5 (15,6%)

Pulmonary Artery Pressure< 25 mmHg26-35 mmHg (mild Pulmonary Hypertension)36-45 mmHg (moderate Pulmonary Hypertension)> 45 mmHg (severe Pulmonary Hypertension)

8 (25%) 6 (18,7%) 8 (25%)

10 (31,3%)

PATIENTS BASELINE ECHOCARDIOGRAPHIC PARAMETERS


Neochordae left in place (n)3 Neochordae (n)4 Neochordae (n)5 Neochordae (n)6 Neochordae (n)

4 (3-4) 10 (31,2%) 15 (46,9%) 6 (18,8%) 1 (3,1%)

Operative time (minutes) 130 (110-150)

Intensive Care Unit stay (hours)< 24 hours24-48 hours> 48 hours

24 (24-24) 27 (84,4%)

2 (6,2%) 3 (9,4%)

Mechanical ventilation time (hours)0 hours (extubation in operative room)< 3 hours3-6 hours> 6 hours

3 (2-3) 9 (28,1%) 3 (9,4%) 3 (9,4%)

Hospital stay (days) 6 (6-9)

Troponin I peak 8.3 (4.4-10.9)

PROCEDURAL RESULTS


Ventricular fibrillation 1 (3,1%)

CPB/ECMO 1 (3,1%)

Bleeding requiring > 2 blood units 3 (9,4%)

Major Adverse EventsDeathStrokeAcute Miocardial InfarctionSepticemia

00

1 (3,1%)1 (3,1%)

Minor adverse eventsPericardial effusionWound dehiscence

Acute Renal Failure needing CVVH (n)Onset of Permanent AF (n)

2 (6.2%)1 (3,1%)

012 (37.5%)

Reoperation for Neochord Failure at 30 daysNew Neochord implantationMitral Valve Replacement

3 (9,4%)1 (3,1%)2 (6.2%)

SAFETY OUTCOMES AT 30 DAYS

EFFICACY OUTCOMES AT 30 DAYS


Intraoperative post-procedure MR0+1+2+

17 (53,1%)10 (31,3%)5 (15,6%)

Residual MR at discharge 0+1+2+

17 (53,1%)10 (31,3%)5 (15,6%)

Residual MR at 30-days0+1+2+3+

14 (43,6%)9 (28,1%)6 (18,7%)3 (9,4%)

NYHA class at 30-daysIIIIII

28 (87,5%)1 (3,1%)3 (9,4%)

MR AND CLINICAL ANALYSIS ACCORDING TO ANATOMICAL

CHARACTERISTICS: 30 DAYS EVALUATION.

MV AnatomicalType

n (%) Success rate (%)

NYHA class

I II III

Type A 8 (26%) 100% 8 (100%)

Type B 16* (52%) 94% 15 (94%) 1 (6%)

Type C 7 (22%) 86% 5 (71%) 1 (14%) 1 (14%)

*one patient excluded from the this analysis considering that the 30-day reintervention was due to a technical issue.

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua – ItalyDepartment of Cardiac, Thoracic and Vascular Sciences, University of Padua – Italy

Freedom from MR >2+/4+according to MV anatomical type

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua – Italy

MR grade at FU for all patients

93% MR

≤2+ at 1

Year


0

5

10

15

20

25

30

35

40

45

Baseline 6 months FU

11% REDUCTION

P = 0,22

mm

MV ANTERO-POSTERIOR ANNULAR DIMENSION


MV LATERO-LATERAL ANNULUS DIMENSION

0

5

10

15

20

25

30

35

40

45


3% REDUCTION

p = 0,64

mm


LEFT VENTRICLE END-SYSTOLIC VOLUME INDEXED

0

10

20

30

40

50

60


12% REDUCTION

p = 0,39

ml/mq

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua – ItalyDepartment of Cardiac, Thoracic and

Vascular Sciences, University of Padua,

Italy

LEFT VENTRICLE END-DIASTOLIC VOLUME INDEXED


0

20

40

60

80

100

120


p = 0,84ml/mq

2% REDUCTION

LEFT ATRIAL VOLUME INDEXED


0

10

20

30

40

50

60

70


18% REDUCTION

p = 0,16ml/mq

PULMONARY ARTERY PRESSURE


0

5

10

15

20

25

30

35

40

45

50


p = 0,05

30% REDUCTION

• TOP-MINI procedure is safe, reproducible, standardized.

• Multiple Neochords are needed

• Good preoperative and intraoperative Imagingassessment improve results

• Early efficacy is demonstrated in particular for Type A and B anatomies and is maintainedover time.

TOP-MINI Summary

• Further refinement of the technique and

preoperative assessment may help to improve

results in challenging (Type C) anatomies.

• Echocardiographic data support the concept

of a trend toward reverse remodelling of the

ventricle and the annulus.

• Longer follow-up in larger series of patients is

needed before drawing more definitive

conclusions

TOP-MINI Summary

TOP-MINI


University of Padua

transapical off-pump mitral valve repair with neochordae

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