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Francesco Maisano San Raffaele Scientific Institute and University Hospital Milano

Maisano Edge To Edge Tor Vergata

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guiding the procedure is key.

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Page 1: Maisano Edge To Edge Tor Vergata

Francesco Maisano

San Raffaele Scientific Institute and University HospitalMilano

Page 2: Maisano Edge To Edge Tor Vergata

First case performed in 1991

Over 1500 published cases accumulated worldwide

About 15 yrs follow-up Technically simple and

reproducible Versatile Criticized by some surgeons

Did not apply correctly Used only as a bailout

Page 3: Maisano Edge To Edge Tor Vergata

Alfieri O et al. JTCVS 2001

Performed in diverse clinical settings: High risk patients Complex anatomy Functional MR

Used to correct anterior and posterior lesions

Annuloplasty has been added whenever possible (90%)

Page 4: Maisano Edge To Edge Tor Vergata

Alfieri O et al. JTCVS 2001; Maisano F et al. EJCTS 1998

Free

dom

from

re

oper

atio

nR

ecur

renc

e of

MR

/ M

S 5 yrs follow-up of 82 pts with severe

Barlow’s disease and bileaflet prolapse

Overall Etiology subgroups

Page 5: Maisano Edge To Edge Tor Vergata

Debonis et al. JTCVS 2005

years

14121086420

Fre

ed

om

fro

m r

eo

pe

ratio

n

1,00

,90

,80

,70

,60

,50

,40

,30

,20

,10

ALP: 96,6 ± 1,74%PLP: 96.2 ± 2.0%

E2E offers the same results as conventional techniques

n.s.

MayoMayo

ClevelandCleveland

Page 6: Maisano Edge To Edge Tor Vergata

The suture must incorporate the diseased segment(s) completely

Respect symmetry Suture lenght should be kept to the

minimum effective to correct MR in order to avoid stenosis

Depth of suture bites is variable according to the nature of the MR

Page 7: Maisano Edge To Edge Tor Vergata

Maisano F et al. EJCTS 1998

Page 8: Maisano Edge To Edge Tor Vergata

Stenosis / Gradients

Suture dehiscence

Role of annuloplasty

Page 9: Maisano Edge To Edge Tor Vergata

Hemodynamics are not influenced by a two orifice configuration of the valve

Pressure gradients are related to the sum of the two orifices area

0

2

4

6

8

(mmHg)

Double (1:1) Double (1:2)Single Q = 11 l/minArea = 2.25 cm2

Maisano F et al. EJCTS 1999

Page 10: Maisano Edge To Edge Tor Vergata

Stresses on the suture are maximum at diastole

Stresses depend on annular size

Redaelli et al. J. Biomechanics 2001

- 647

- 520

- 394- 267

- 140

- 134

+ 113+ 240

+ 367

+ 493

+ 620+ 747

+873

+1000

SI (kPa)

Page 11: Maisano Edge To Edge Tor Vergata

Annuloplasty has been routinely added to the Alfieri procedure Absence of annuloplasty is associated with increased stresses on the

suture and on the valve structures Absence of annuloplasty may be associated with accelerated failure

(but not in multivariate analysis)

- 647- 520 - 394- 267- 140 - 134+ 113+ 240+ 367+ 493+ 620+ 747+873+100

0

SI (kPa)

Alfieri et al. JTCVS 2001, Maisano et al JTCVS 2003, Nielsen et al Circulation 2005

Page 12: Maisano Edge To Edge Tor Vergata

Maisano F et al. Eurointervention 2006

Page 13: Maisano Edge To Edge Tor Vergata
Page 14: Maisano Edge To Edge Tor Vergata

Guide

Steerable sleeve

Clip delivery handle

Stabilizer

Atrial Septum

Page 15: Maisano Edge To Edge Tor Vergata

Enrollment Population nEVEREST IFeasibility (completed)

Registry patients 55

EVEREST IIRandomized n=244

Roll-in Randomized ClipRandomized Surgery

6017288

EVEREST II High Risk Registry 78

Total enrolled 453

Page 16: Maisano Edge To Edge Tor Vergata
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79 pts

Page 19: Maisano Edge To Edge Tor Vergata

SURGERY FREE

76/104

Surgery After Clip Implanted (n = 20)• 15 (75%) Repairs (0 - 562 days)

• 5 (25%) Replacements

Surgery After No Clip (n = 8)• 5 (63%) Repairs

• 3 (37%) Replacements

71% Repaired

Page 20: Maisano Edge To Edge Tor Vergata

Applicable only to central MR originating from A2-P2

Not applicable in case of wide prolapse

Not applicable in case of annular dilatation

mid esophageal 120°

mid esophageal 90°

mid esophageal 120°

Maisano F, et al Am J Cardiol 2007;99:1434–1439

SL AL

<10% of current surgical candidates

Page 21: Maisano Edge To Edge Tor Vergata

When performed according to surgical principles, the E2E technique provides results at least non inferior to other surgical techniques

Precision of the repair is mandatory for efficacy and durability Pt selection + include all diseased segments + respect symmetry

Patients with normal annular function may undergo ringless repair, although lower durability may be expected

Percutaneous approach is feasible also in FMR Addition of annuloplasty should be an option also

for percutaneous patients

Page 22: Maisano Edge To Edge Tor Vergata

66 aa, maschio, 64 Kg, 164 cm, BSA 1.7 m2, BMI 24

IM 4+, FE 15-20%, PAPs 75 mmHg, disfunzione VDx, IT 3+

1994 IMA anteriore; 2001 PTCA e successivo CABG (LIMA—LAD);

successive plurime PTCA con stents medicati

2005 AlloTx di midollo per AML, inizia CsA

2006 stenting a. carotide comune e interna destra

1/2008: recidiva di IMA per trombosi intrastent POBA su LAD

4/2008 EPA PM-ICD biv

AAA sottorenale; CCS II, NYHA II, labile compenso emodinamico

Anamnesi-1 Paziente n. 1Paziente n. 1

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