Sutureless valves
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Sutureless Aortic Valves Hani K. Najm MD, Msc, FRCSC,, FACC, FESC Head of Cardiac Surgery King Abdulaziz Cardiac Centre National Guard Health Affairs Riyadh, Saudi Arabia
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Sutureless valve
Sutureless fixation of the valve onto a debris free aortic
annulus combines the advantages of open surgical AVR and TAVI.
Sutureless valve available: Perceval S Intuity valve system 3f enable valve.
Advantages of sutureless vavlve Complete excision of the diseased valve. Anatomical tailoring to individual patient anatomy. Atraumatic introduction with minimal or no crimping of the the
valve leaflets allowing more predictable long term outcomes Valves are self anchoring ( no need for sutures), self expanding for
easy implantation and good visibility Shorter CPB Permits minimally invasive cardiac surgery procedures while
delivering gold standard surgical outcome.
Perceval S
Perceval S – the design Outflow Ring: at the STJ level
Sinusoidal Struts: anchoring into Valsalva Sinuses Straight commissural struts: supporting the valve Inflow tissue ring 7
Perceval S – Design Features Using well known biological valve design – more
than 20 years of Sorin pericardial tissue valve expertise Innovative sutureless anchoring into the aortic
root anatomy by a unique anchoring system made of shape memory alloy All non-biological surfaces coated with
Carbofilm™ (highly biocompatible carbon coating) 8
Perceval S – collapsing system •
•
A minimal and atraumatic collapsing device ensures creaseproof valve tissue Low profile (12 mm) ideal for small aortic roots and annuli Collapsed Outflow Ring Valve Leaflets are creaseproof Collapsed Inflow Ring
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Perceval S – collapsing system Valve Leaflets are creaseproof
Collapsed Outflow Ring Collapsed Inflow Ring
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Perceval S Clinical Experience Enrolment Status Patients No Follow Up Indications Endpoints Size Surgical Approach
Complete Apr 2007-Feb 2008
Complete Jan 2009-Jan 2010
Ongoing Feb 2011
30 pts – 3 EU centres
150 pts – 9 EU centres
570 pts implanted 26 EU centres
to 5 yrs ongoing
to 5 years ongoing
Ongoing
Patients ≥ 75years
Patients ≥ 75years
Feasibility Safety 30 days
Safety & Effectiveness months
S-M
S-M
S–M–L
Median sternotomy
Median & Mini Sternotomy
Median & Mini Sternotomy
3-6
Patients ≥ 65years Safety & Effectiveness 12 months
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Pooled PILOT and PIVOTAL Trial – Study design Primary Objective Study Design Patient population Major Inclusion Criteria Major Exclusion Criteria
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Safety and effectiveness of the Perceval S valve
Prospective, Multicentre, European, Non-randomized
Adult patients (>75 yrs) with aortic stenosis or stenoinsufficiency • Patients > 75 years old • NYHA Class III or IV and Log Euroscore > 5% • Aortic annulus in the range 19 - 23 mm
• Pure aortic insufficiency • Congenital bicuspid aortic valve • Concomitant procedures other than CABG or septal miectomy • Subjects with AMI within 3 months • Subjects with aortic root enlargement
• Clinical experience on 659 patients • Over 4 years follow-up • 3 consecutive trials in 26 Centers in 8 European Countries • Surgical access: median and mini-sternotomy • Age: ≥ 65 years • Mean STS score: 9.6 • Available sizes: S- M – L
Perceval S - Indications
AVR patients ideal for a Perceval S:
Small Aorta Small Annuli Calcified Aortic root Compromised pre-
Higher-risk
operative contractile function
Respiratory
patients
requiring concomitant procedure (CABG) (COPD)
disorders
Major Inclusion Criteria
• Adult patients (>75 yrs; >65 yrs from 2010) with aortic stenosis or steno-insufficiency • Aortic annulus in the range 19 – 25 mm
Major Exclusion Criteria
• Pure aortic regurgitation • Congenital bicuspid aortic valve • Subjects with aortic root enlargement
Demographic Data Implant period
April 2007 – September 2011
Mean age
79 ± 5 yrs (63-92 yrs)
Gender (Female)
67.7%
EuroScore (%)
11.27 ± 8.44
STS score (%)
9.60 ± 5.85
Age distribution
More than 40% of pts older than 80 years
Diagnosis
Concomitant procedures
Surgical approach
Median Sternotomy Isolated AVR
Complex AVR
Mean±SD
Mean±SD
X-clamp (min)
31.0 ±11.0
52.2 ±24.2
Pump time (min)
51.3 ±19.8
80.6 ±34.5
Mini-Sternotomy Isolated AVR Mean±SD
X-clamp (min)
37.7 ±12.2
Pump time (min)
65.6 ±21.4
80
Implanted size
70
60
50
g H m
Mean Gradient Peak Gradient
40
30
20
10
0 Preoperative
Discharge/1 month
3-6 months
12 months
3 years
Perceval S experience
LV mass and LV mass indexed by visit - 3y 280
160 143,6
260 258,5
140
130,1 122,5
240
121,5 120
232,1
220
214,2 200
88,8
100
g
80 180
g/m ²
207,4 LV mass LV mass indexed 60
160 152,4
140
40
20
120
100
0 Preoperative
15/04/13
Discharge/ 1 month
3-6 months
12 months
3 years
No thrombosis No post-operative migrations No SVD Early cardiac mortality 1.6% (late 0.6%) Major stroke 1.9% (late 0.6%) Major PVL 1.1% (late 0.6%)
Perceval S clinical benefits Perceval S significantly reduces the mortality
Brown JM et al; J Thorac Cardiovasc Surg 2009 Jan;137(1):82-90. Martyn T et al. Circulation. 2010;122:62-69 24
Perceval S clinical benefits with economic relevance Clinical Outcome Perceval S
C-AVR
TAVI
Length of stay
11
11.8
18
(days) ICU stay
2.1
2.7
4.5
(days)
ICU Hospital Stay /day = 1164 € (Germany) Ward Hospital Stay /day = 724 € (Italy) Perceval S Sutureless Valve – Special Indications; Fischlein, EACTS 2011
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The clinical experience on 659 patients up to 4 years follow-up shows the Perceval S :
Makes AVR a reproducible and easy procedure
- Clear and rapid
Implant Technique - Minimally invasive AVR can gain broader access
Minimizes Aortic Cross Clamping Time
Enhances hemodynamic performances
Delivers excellent clinical outcomes
It represents our choice for medium - high risk patients
INTUITY VALVE SYSTEM
Indications and Contraindications INDICATIONS For patients whose aortic
valve disease is sufficiently advanced to warrant replacement of their native valve Also intended for re-do
patients in which the previously implanted prosthesis is excised and replaced with the EDWARDS INTUITY valve
CONTRAINDICATIONS • Pure aortic insufficiency • Aneurysms of the aortic root or ascending aorta • History of active endocarditis within 3 months of scheduled surgery Warning: The safety and effectiveness of the EDWARDS INTUITY valve has not been established for patients with a congenital bicuspid or unicuspid aortic valve, because it has not been studied in these populations
EDWARDS INTUITY Valve System Aortic Valve
• Sterilized in glutaraldehyde • Valve is inverted in the jar to facilitate attachment of the delivery system
Delivery System
• Ethylene oxide (ETO) sterilized • Components secured on a plastic card • Single barrier peel pouch
Inflation Device
• Ethylene oxide (ETO) sterilized • Secured in a tray • Single barrier peel
Procedure Review
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Examples of Standard Aortotomies
Transverse
Hockey Stick
Lazy S
Leaflet Excision
Annular Debridement ď “
Annulus with calcification
Calcification removed
• Debride calcium from the annulus to ensure proper seating of the valve and to avoid damage to the valve leaflets
Anatomic and Valve Considerations For Sizing
Supra-annular Intra-annular Sub-annular
Sizing
Click to show this part of the sizing process
Visual assessment of native annulus to determine approximate size
Select appropriate sizer
Size the annulus choosing the largest diameter barrel end that is a snug fit in the annulus
If the annular dimension is assessed to fall between valve sizes, selection of the smaller size valve is recommended
Guiding Suture Placement in the Annulus
Conventional suture Non-Everting
techniques, such as noneverting mattress, figure of eight or simple can be used with this valve
Three annular sutures equally
spaced and placed in the middle of each sinus to guide the valve onto the annulus
Figure of Eight
Non-pledgetted, braided
sutures are recommended
Guiding Suture Placement on the Valve
First inspect the valve before implant for evidence of extreme temperature exposure or other damage
Secure valve by holding distal handle
Place each suture through the sewing ring in positions corresponding to the annular suture positions
Avoid inserting too deeply through sewing ring
Lowering Valve to the Annulus • Lower valve onto the annulus using the distal handle
• Pull up on guiding sutures to maintain tension
Valve Seating ď “
Tilt valve left to right to ensure ideal seating
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Confirm sutures on sewing ring and sutures in the annulus align properly
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Once seated, maintain downward pressure on distal handle
Use of Snares
Thread guiding suture through snare or tourniquet using a snare hook
Pull upward on guiding suture and anchor distal end of snare with hemostat
Repeat for all guiding sutures
Valve Inspection
Confirm valve seating
Confirm valve position
Close the aortotomy
Key results One-year follow-up details
Key results One-year follow-up details
Key results Safety endpoints: PVL
Step 3: Key results Procedure times
Step 3: Key results Procedure times
Step 3: Key results Hemodynamic performance at 1 year
Key messages to deliver
Safe, feasible, and efficacious Offers flexibility of approach: full, upper mini-sternotomy Reduced aortic crossclamp and cardiopulmonary bypass
times Early hemodynamic performance was excellent and
remained so up to 1 year
King Abdul Aziz Cardiac Center experience 22 Perceval implants (first out of Europe implants) Mean age 75 years Concomitant procedure in 13 1 mortality unrelated to valve Post op gradient mean of 8 mmHg No paravalvular leak 4 Intuity valves (first out of Europe implants) Mean age 65 years No mortality or morbidity Post op gradients mean of 9 mmHg
Conclusions
Sutureless aortic valve replacement is safe and has excellent
early and mid outcome Perfectly suitable for small aortic roots and poor ejection
fraction patients Reduces ischemic and pump time Long term outcome is still awaited.