AorticAortic Valve Valve ReplacementReplacement in in currentcurrent

and future and future CardiacCardiac SurgerySurgery

Mattia Glauber, MDMattia Glauber, MDFondazione Fondazione G. Monasterio CNR Regione Toscana, MassaG. Monasterio CNR Regione Toscana, Massa

�� Traditional Valve SurgeryTraditional Valve Surgery

�� MechanicalMechanical

�� BiologicalBiological

�� TAVITAVI

�� SuturelessSutureless

What are the current AVR What are the current AVR

options?options?

Traditional Valve SurgeryTraditional Valve Surgery

�� Traditional Valve Surgery is the gold standardTraditional Valve Surgery is the gold standard

Inserire referenza paper

Brown J. M. et al.; J Thorac Cardiovasc Surg 2009;137:82-90

Risk-adjusted mortality for aortic valve replacement during 10

years in the Society of Thoracic Surgeons database

TAVI is expanding indicationsTAVI is expanding indications

�� From inoperable patients to high risk patients From inoperable patients to high risk patients

but…..but…..

TAVI results are far from the gold TAVI results are far from the gold

standardstandard

Source: Partner StudySource: Partner StudyMonths Post Procedure

Mor

talit

y

None - Trace

Mild

Moderate - Severe 50.7%

26.3%

33.4%35.3%

12.7%

26.2%

p (log rank) < 0.001

HigherHigher mortality correlated to mortality correlated to

higher incidence of PVL in TAVIhigher incidence of PVL in TAVI

None-Trace

Severe

Mild

At 2 years, mortality in TAVI from 26.3% up to 50.7%At 2 years, mortality in TAVI from 26.3% up to 50.7%

Why Why SuturelessSutureless Valves?Valves?

Aims:Aims:

�� Cure the diseaseCure the disease

�� Reduce ischemic timeReduce ischemic time

�� Improve patient survivalImprove patient survival

�� Improve hemodynamic performanceImprove hemodynamic performance

Rationale:Rationale:

�� Easier and faster AVR procedureEasier and faster AVR procedure

�� Reproducible procedureReproducible procedure

�� Favor Minimally invasive techniquesFavor Minimally invasive techniques

�� Enable concomitant proceduresEnable concomitant procedures

# of patients in

clinical trials775 170 150

in the market

sinceJanuary 2011 December 2009 (1

st gen) February 2012

Biological design

platform

Pericarbon Stentless

(CE Mark 1991)

ATS 3f Stentless

(CE Mark 2005)

Magna Ease

(CE Mark 2007)

Self-expandable Yes Yes No

Rinsing Not required 3 times for 30 sec 2 times for 60 sec

Sutures Not required 1 suture 3 sutures

Collapsible Yes (collapsing tool) Yes (manual) No

Annulus direct

visualizationYes No No

SuturelessSutureless Valve SnapshotValve Snapshot

Medtronic

3f Enable I

Edwards

Intuity

Sorin

Perceval S

OurOur SuturelessSutureless AVR AVR experienceexperience

Sutureless Valves

implanted in

Massa

Patients

treated

Cases performed in

Minimally invasive

approach

Sorin Perceval S 121 100

Medtronic 3F

Enable

32 10

Edwards Intuity 6 1

Perceval S: Reproducible procedurePerceval S: Reproducible procedure

Short and Fast Learning Curve

# procedures

confidence

31 5

low

medium

high

7

Collapsing

Delivery

Visual control

�� Easy and fast procedureEasy and fast procedure

�� Short learning curveShort learning curve

Perceval S: faster procedurePerceval S: faster procedure

�� Cross Clamp Time (XCT) and Cross Clamp Time (XCT) and CardiopulmunaryCardiopulmunary ByBy--

pass Time (CBT) savings with Perceval S pass Time (CBT) savings with Perceval S vsvs

traditional valves in right anterior traditional valves in right anterior minithoracotomyminithoracotomy

and and ministernotomyministernotomy approaches:approaches:

--48 minutes (48 minutes (--53%)53%)

--55 minutes (55 minutes (--43%)43%)

--47 minutes (47 minutes (--56%)56%)

--66 minutes (66 minutes (--54%)54%)XCTXCT

CBTCBT

Why time saving is vital importance?Why time saving is vital importance?

Perceval S: clinical outcomePerceval S: clinical outcomeRight Anterior

Minithoracotomy

(94)

Ministern. (6) Full Stern.

(21)

All cause mortality 0 0 0

Stroke 1 1 1

Re-exploration for bleeding 2 0 3

Transfusion 17 1 9

Renal Failure 0 0 2

Wound Infection 0 1 1

Migration 0 0 0

PM implants 0 0 1

Paravalvular Leak 2 0 0

Structural Valve Deterioration 0 0 0

Thrombosis 0 0 0

Freedom from endocarditis 100% 100% 100%

Freedom for reoperation 100% 100% 100%

Mean Follow-up: 8,5 months (range 1 -18)

Perceval S: faster recoveryPerceval S: faster recovery

Right Anterior

Minithoracotomy

Ministernotomy Full

sternotomy

ICU stay median

(days)

1 1 1

Hospital

discharge (days)

5.8 (4 -14) 7 (5-9) 9

Perceval S: enhancing MICSPerceval S: enhancing MICS

�� Valve Profile is significantly reduced, allowing Valve Profile is significantly reduced, allowing atraumaticatraumatic

insertioninsertion

�� No need of sutures (No need of sutures (n.wiresn.wires, # knots), critical issue in , # knots), critical issue in

MICS approachesMICS approaches

PercevalPerceval S S isis mountedmounted on on dedicateddedicated holderholder

Ministernotomy

Right Ant. Minithoracotomy

Perceval S: facilitating Complex Perceval S: facilitating Complex

procedures and REDOprocedures and REDO

�� In all complex procedures, Perceval S is particularly valuable In all complex procedures, Perceval S is particularly valuable

for its considerable reduction in implantation timefor its considerable reduction in implantation time

�� With simple and straight surgical procedure Perceval S With simple and straight surgical procedure Perceval S

dramatically speeds up surgeriesdramatically speeds up surgeries

Our world of Cardiac therapies is changing…Our world of Cardiac therapies is changing…

Surgery remains the gold standard and can benefit Surgery remains the gold standard and can benefit

from innovative technologies in the surgical arena from innovative technologies in the surgical arena

improving patient outcomesimproving patient outcomes

TechnologyTechnology isis changingchanging

at at warpwarp speedspeed

� Sutureless facilitates all AVR Minimally Invasive approaches and complex procedures

� Minimally Invasive AVR & Sutureless valves mayrepresent an alternative to TAVI on medium-high riskpatients

OurOur vision on vision on SuturelessSutureless

In the future………… we would like

to use this technology

with Minimally Invasive approach

for every patient!

Thank you

http://www.youtube.com/watch?v=GHKQCfhYwfg

mattia.glauber@ftgm.it