Transcript First Large Cohort with a Sutureless Aortic Valve: the 1 Year

FIRST LARGE COHORT WITH A SUTURELESS
AORTIC VALVE: THE 1 YEAR FOLLOW-UP OF
628 CONSECUTIVE PATIENTS FROM AN
INTERNATIONAL MULTICENTER PROSPECTIVE TRIAL
Theodor Fischlein, Bart Meuris, Kavous Hakim-Meibodi, Martin Misfeld,
Thierry Carrel, Marian Zembala, Sara Gaggianesi, Francesco Madonna,
François Laborde, Axel Haverich
on behalf of the Cavalier Trial Investigators
The Perceval Sutureless valve is currently not approved for sale in US
Disclosure
• T. Fischlein, B. Meuris, and F. Laborde are consultant for Sorin
Group
• The trial was funded by Sorin Group
Study Design
• Prospective, non-randomized, multi-center trial
• Primary endpoints:
• Safety (mortality and morbidity) and Effectiveness (clinical status end
haemodynamic performance improvement) @ 1 year
• Clinical Event Committee (CEC) for independent review and
adjudication of adverse events
• Yearly follow up to 5 years
PERCEVAL
Main In/Exclusion Criteria
Inclusion Criteria
Male/female ≥ 65 years old
Aortic valve stenosis or steno-insufficiency
Eligible to AVR with biological prosthesis
Willing to sign informed consent
Willing to undergo all
• medical follow-ups
• echocardiography examinations
• laboratory tests
Exclusion criteria
Preexisting valve prostheses (mitral,
pulmonary or tricuspid)
Double/triple valve replacement
Simultaneous cardiac procedures (except
septal myectomy and/or coronary bypass)
Active endocarditis/myocarditis
Congenital bicuspid valve
Aneurysmal dilation or dissection of the
ascending aortic wall
Sino-tubular junction and the annulus
diameter >1.3
CAVALIER Trial - Study Overview
120
100
 Enrollment : February 2010 – September 2013
 5 year follow-up ongoing
 25 Centers in 8 European Countries
80
60
40
20
0
 658 operated patients
 Surgical access: median sternotomy/minimally
invasive access

Available sizes: S, M, L, XL
Study Flow Chart
MAIN REASONS FOR
NOT RECEIVING PERCEVAL
Patients Enrolled
n = 815
Patients with Perceval
valve attempt
n = 658
Patients included
n = 628
Excluded before implant N=157
(not meeting Inclusion Criteria)
Different prosthesis implanted
n =30
Death
n =50
Explant
n =12
Patient withdrawal
n = 15
Patient lost to F-up
n=2
1-year Follow-Up
n = 549
• 66 (42%) Valve size not available
• 16 (10%) Congenital Bicuspid valve
• 12 (8%) Ratio STJ/Annulus > 1.3
• 9 (5.7%)Withdrawn consent
The Perceval Valve
Valve Features
• Bovine pericardium
• Double-sheet design
• Eyelets for guiding
suture positioning
• Self-Anchoring Frame
• Self-expanding, Ni-Ti alloy
• Anatomical design to fit
Valsalva sinuses
• Double-ring geometry
• Carbofilm™ coating
Patient demographics
Demographic
658 patients
Mean age (range)
Males
Females
78.3 ± 5.6 (61.6 ; 92.6)
234 (35.6%)
424 (64.4%)
40% of patients octagenarian
Age distribution
NYHA Classification
4.9% 0 3.3%
7,3%
40,0%
30.1%
52,7%
< 70
70-79
≥80
58.7%
NYHA I
NYHA III
NYHA II
NYHA IV
Preoperative risk factors n=658
Systemic hypertension
83.7%
Diabetes*
29.0%
Extracardiac arteriopathy
17.0%
Chronic lung disease
15.7%
Renal insufficiency
14.8%
Mean STS Score ± SD: 7.2 ± 7.4
Cerebrovascular disease
11.4%
Active Smokers
4.7%
0%
* Insulin dependent diabetes: 9.6%
(Min - Max: 0.8 – 50.0)
10%
20%
30%
40%
50%
60%
70%
80%
90%
Surgical details
Valve size
50%
44.1%
45%
38.8%
Surgical approach
OVERALL
(N=658)
Median sternotomy
439 (66.7%)
Minimally invasive access
40%
Ministernotomy / Minithoracotomy
219 (33.3%)
35%
30%
Concomitant Cardiac
Procedures
25%
20%
15%
CABG
12.8%
10%
4.4%
5%
0%
S
M
L
XL size implants started in July 2012
XL
194 / 658 (29.5%)
154 (23.4%)
Septal myectomy
22 (3.3%)
Afib treatment
20 (3.0%)
Tricuspid valve repair
7(1.1%)
Congenital defect closure
3 (0.5%)
Other
4 (0.6%)
Note: Patients may have more than one concomitant surgical procedures
Surgical Approach
Median Sternotomy (439)
CPB Time (min)
79.3
CPB Time (min)
Minimally Invasive Access (219)
X-Clamp Time (min)
X-Clamp Time (min)
64.4
53.9
53.0
38.7
33.2
Isolated
70.9
Concomitant Cardiac
Procedures
Isolated
43.9
Concomitant Cardiac
Procedures
Mortality
Early
(≤ 30 days)
n=628
Late @ 1 yr
(>30 days)
n = 600
n (%)
n (%)
22 (3.5)
28 (4.6)
Cardiac deaths
16 (2.5)
12 (2.0)
Non cardiac deaths
6 (0.9)
16 (2.7)
Any death
Freedom From Overall Death
Freedom From Cardiac Death
91.75%
1 month
3 months
6 months
9 months
12 months
96.32 % (94,84 % - 97.79 %)
94.06 % (92.02 % - 95.78 %)
93.24 % (91.27 % - 95.22 %)
92.58 % (90.52 % - 94.65 %)
91.75 % (89.59 % - 93.92 %)
95.43%
1 month
3 months
6 months
9 months
12 months
97.43 % (96.19% - 98.67 %)
96.61 % (95.18 % - 98.03 %)
95.94 % (94.38 % - 97.5 %)
95.6 % (93.97 % - 97.22 %)
95.43 % (93.77% - 97.08 %)
Morbidity
Early
(≤ 30 days)
n = 628
Late @1 year
(> 30 days)
n = 600
n (%)
n (%)
Reintervention for bleeding
27 (4.3)
0 (0.0)
Explant
6 (0.9)
6 (1.0)
Primary PVL
5 (0.8)
2 (0.3)
4 (0.4)
0 (0.0)
Stroke
14 (2.2)
5 (0.8)
Endocarditis
1 (0.2)
8 (1.3)
Leading to explant
0 (0.0)
5 (0.8)
Hemolysis (clinically significant)
1 (0.2)
1 (0.2)
SVD
0 (0.0)
0 (0.0)
Valve Thrombosis
0 (0.0)
0 (0.0)
AV block III leading to Pace Maker Implant
51 (8.1)
9 (1.5)
Leading to explant
Clinical Status
NYHA Class
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
NYHA III-IV:
63.2%
NYHA I-II: 89.9%
preoperative
12 months
IV
III
II
I
Hemodynamic data at 1 year
1.6
1.4
1.5
1.5
1.5
50
45
45
40
1.2
35
1
30
0.8
25
0.7
20
0.6
15
0.4
10.3
0.2
8.9
9.2
0
10
5
0
Preoperative
Discharge
3-6 months
12 months
EOA (cm2)
MPG (mmHg)
LV mass regression by follow-up interval
in paired patients (n=126)
P <0.01
300
MEAN LV MASS - g
250
200
150
100
50
0
Discharge (N=126)
3/6 Month (N=126)
12 Month (N=126)
Conclusion
•
High implant success rate (95%)
•
Very promising outcomes, with a low rate of cardiac mortality, stroke, major paravalvular
leaks, and valve explants, despite the risk profile of the of patients (40% octagenarians;
mean STS score 7.2)
•
Early (2.5%) and one year (4.6%) cardiac mortality rates are favorable/comparable to those
reported in the literature
•
Proved suitability of the Perceval Valve in the conventional full sternotomy as well as the
minimally invasive approach
•
Clinical status (NYHA class) improved to at least one class in 77.5% of patients and
remained stable during the FU
•
Transvalvular gradient reduction was significant and stable resulting in a improvement in left
ventricular mass (p<0.01) up to 1 year
Acknowledgments
Thierry Folliguet
Kostantinos Zannis
Steffen Pfeiffer
Giuseppe Santarpino
Malakh Shrestha
Samir Sarikouch
Jan F. Gummert
Friedrich W. Mohr
Pascal Dohmen
Mario Stalder
Eva Roost
Krzysztof Filipiak
Tomasz Niklewski
Cardiac Medico-Surgical Department,
Institute Mutualiste Montsouris, Paris, France
Cardiac Surgery, Paracelsus Medical University, Klinikum
Nürnberg, Nuremberg, Germany
Cardio-thoracic, Transplantation & Vascular Surgery,
Hannover Medical School, Germany
Klinik, Herz- und Diabeteszentrum,
Bad Oeynhausen, Germany
Herzzentrum der Universität Leipzig,
Klinik fur Herzchirurgie, Leipzig, Germany
Inselspital, University of Bern,
Bern, Switzerland
Silesian University Center for Heart Disease,
Zabrze, Poland
Xavier Roques
Hopital Cardiologique Du Haut- Lévêque,
Pessac, France
Willem J. Flameng
Cardiac Surgery, U.Z. Gasthuisberg,
Leuven, Belgium
Axel M.M. Laczkovics
Ruhr University of Bochum,
Department of Cardiothoracic Surgery,
Bochum, Germany
Matthias Bechtel
Alain G. Prat
Carlo Banfi
Otto E Dapunt
Harald C. Eichstaedt
Centre Hospitalier Regional Universitaire,
Lille, France
Klinikum Oldenburg, Department of Cardiovascular Surgery,
Oldenburg, Germany
Wolfang Harringer
Ulrike Carstens-Fitz
Department of Thoracic and Cardiovascular Surgery,
Klinikum Braunschweig, Braunschweig, Germany
Tom J. Spyt
Regional Cardiothoracic Unit, Genfield General Hospital,
Leicester, United Kingdom
Jan Gerhard
Wimmer-Greinecker
Matthias Machner
Herz und Gefäßzentrum,
Bad Bevensen,Germany
Erwin S.H. Tan
Filip P.A. Casselman
Catharina Ziekenhuis,
Eindhoven, Netherlands
OLV Clinic - Department of Cardiovascular and Thoracic
Surgery, Aalst, Belgium
Alaaddin Yilmaz
Uday Sonker
Sabine Bleiziffer
Saint Antonius Hospital,
Nieuwegein, Netherlands
Peter J. Oberwalder
Medical School Graz, Department of Cardiac Surgery,
Graz, Austria
Alfred A. Kocher
Rainald Seitelberger
Hendrik Treede
Leonard Conradi
Riccardo Cocchieri
Bas De Mol
Jean-Christian
Roussel
Philippe Despins
Heinz G. Jakob
Daniel Wendt
Department Cardiothoracic Surgery,
Medical University, Vienna, Austria
German Heart Center, Munich, Germany
Universitäres Herzzentrum Hamburg GmbH,
Hamburg, Germany
Amsterdam Medical Centre - AMC,
Amsterdam, Netherland
Centre Hospitalier Universitaire,
Nantes, France
Department of Thoracic & Cardiovascular Surgery,
University of Essen, West German Heart Center,
Essen, Germany
Thank you!
www.klinikum-nuernberg.de