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Francesco Maisano
San Raffaele Scientific Institute
and University Hospital
Milano
 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
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%)
Alfieri O et al. JTCVS 2001; Maisano F et al. EJCTS 1998
Freedomfrom
reoperation
Recurrence
ofMR/MS
5 yrs follow-up of 82
pts with severe
Barlow’s disease and
bileaflet prolapse
Overall Etiology
subgroups
Debonis et al. JTCVS 2005
years
14121086420
Freedomfromreoperation
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
 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
Maisano F et al. EJCTS 1998
Stenosis / Gradients
Suture dehiscence
Role of annuloplasty
 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/min
Area = 2.25 cm2
Maisano F et al. EJCTS 1999
 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)
 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
Maisano F et al. Eurointervention 2006
Guide
Steerable sleeve
Clip delivery handle
Stabilizer
Atrial
Septum
Enrollment Population n
EVEREST I
Feasibility (completed)
Registry patients 55
EVEREST II
Randomized n=244
Roll-in
Randomized Clip
Randomized Surgery
60
172
88
EVEREST II High Risk Registry 78
Total enrolled 453
79 pts
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
 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
 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
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
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata
Maisano Edge To Edge Tor Vergata

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Maisano Edge To Edge Tor Vergata

  • 1. Francesco Maisano San Raffaele Scientific Institute and University Hospital Milano
  • 2.  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
  • 3. 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%)
  • 4. Alfieri O et al. JTCVS 2001; Maisano F et al. EJCTS 1998 Freedomfrom reoperation Recurrence ofMR/MS 5 yrs follow-up of 82 pts with severe Barlow’s disease and bileaflet prolapse Overall Etiology subgroups
  • 5. Debonis et al. JTCVS 2005 years 14121086420 Freedomfromreoperation 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
  • 6.  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
  • 7. Maisano F et al. EJCTS 1998
  • 8. Stenosis / Gradients Suture dehiscence Role of annuloplasty
  • 9.  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/min Area = 2.25 cm2 Maisano F et al. EJCTS 1999
  • 10.  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)
  • 11.  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
  • 12. Maisano F et al. Eurointervention 2006
  • 13.
  • 14. Guide Steerable sleeve Clip delivery handle Stabilizer Atrial Septum
  • 15. Enrollment Population n EVEREST I Feasibility (completed) Registry patients 55 EVEREST II Randomized n=244 Roll-in Randomized Clip Randomized Surgery 60 172 88 EVEREST II High Risk Registry 78 Total enrolled 453
  • 16.
  • 17.
  • 19. 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
  • 20.  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
  • 21.  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
  • 22. 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