the carbomedics top hat experience. · background • the carbomedics top hat (cm-th) aortic...
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The Carbomedics Top Hat
Supra-Annular Aortic Valve: A
22-year single-surgeon
experience.
Kinga Kosiorowska
Edward J Caruana
Ian M Mitchell
Trent Cardiac Centre, Nottingham, UK
Background
• The Carbomedics Top Hat (CM-TH) aortic prosthesis
was designed to lie in the supra-annular position, thus
facilitating insertion of a larger valve.
• The low-profile mount offers a larger effective orifice
area (EOA) in sizes 23+ [vs Carbomedics Standard
(CM-St)].
Background
• Higher-positioning of the valve allows for deeper
anchoring sutures to be taken; of particular value in
fragile tissues.
• The large sewing ring adapts to the irregular contours
of calcific aortas; possibly reducing paravalvular leaks.
• Despite concerns of compromising coronary flow and
perfusion, this has never been encountered clinically by
the authors.
Purpose
• To report on a vast single-surgeon experience with
supra-annular mechanical valves (CM-TH), spanning
22-years of consultant practice.
Methods
• All patients receiving the Carbomedics Top Hat (CM-
TH) aortic valve prosthesis between 1995 and 2017
identified from prospective local cardiac surgical
database - single-surgeon, single-centre (UK).
• Contemporary control-group receiving Carbomedics
Standard (CM-St) aortic valve prosthesis identified -
same-surgeon, same-centre.
• Survival data obtained from national database (NHS
Spine).
Methods
• Descriptive statistics, Pearson’s chi squared and two-
way analysis of variance (ANOVA) performed using the
Analyse-it® package for Microsoft Excel 365.
• Kaplein Meier analysis performed using Stata/IC
(v14.1).
• Propensity-matching (1:1) of CM-TH with CM-St
control, modelled on age, gender, NYHA functional
class, BSA, LVEF, and logistic EuroSCORE was
performed in R Statistics (v3.4.3).
Results CM-TH Frequency
N = 244
Results CM-TH Baseline Characteristics
Age (y) 61±10
Male 138 (57%)
BSA (sqm) 1.9±0.3
LVEF
good
moderate
201 (82%)
30 (12%)
PCS 14 (6%)
Log EuroSCORE
(%) 5.3±4.9
Valve Pathology
AS
AS & AR
141 (58%)
57 (23%)
Results CM-TH Operative Data
Procedure
isolated AVR
concomitant CABG
175 (72%)
51 (21%)
Urgency
elective
urgent
203 (83%)
40 (16%)
CPB Time (min) 94±27
X-Clamp Time (min) 70±18
Results CM-TH Valve Data
Valve Size Implanted Patient-Prosthesis Mismatch ‘moderate’ if 0.65-0.85, ‘severe’ if <0.65.
Results CM-TH Post-Operative Survival
Survival
30-day
1-year
5-year
10-year
237/244 (97%)
222/234 (95%)
136/164 (83%)
81/110 (74%)
Results Propensity Matching
Results CM-TH vs CM-St Baseline Characteristics
CM-St CM-TH
(all) p-value
CM-TH
(matched) p-value
N 113 244 - 113 -
Age (y) 61±10 61±10 NS 61±10 NS
Male 90 (80%) 138 (57%) <0.0001 67 (60%) 0.0009
BSA (sqm) 1.9±0.2 1.9±0.3 NS 1.9±0.4 NS
LVEF
good
moderate
64 (57%)
41 (36%)
201 (82%)
30 (12%)
<0.001
73 (65%)
27 (24%)
NS
PCS 6 (5%) 14 (6%) NS 8 (7%) NS
Log EuroSCORE
(%) 6.2±9.2 5.3±4.9 NS 6.1±5.7 NS
Valve Pathology
AS
AS & AR
58 (51%)
20 (18%)
141 (58%)
57 (23%)
0.03
59 (52%)
30 (27%)
NS
Results CM-TH vs CM-St (Matched) Peri-Operative Data
CM-St CM-TH p-value
Procedure
isolated AVR
concomitant CABG
79 (70%)
28 (25%)
84 (74%)
22 (20%)
NS
Urgency
elective
urgent
95 (84%)
16 (14%)
92 (81%)
20 (18%)
NS
CPB Time (min) 98±28 94±28 NS
X-Clamp Time (min) 76±19 70±17 0.01
Valve Size (med,
IQR) 23 (21-25) 23 (21-23) 0.02
PPM
moderate
severe
45 (40%)
10 (9%)
18 (16%)
1 (1%)
<0.0001
Results CM-TH vs CM-St (Matched) Survival Data
Limitations
• retrospective analysis of generic prospectively-
populated database
• no haemodynamic or medium-to-long term complication
data
• no quality of life measures
• low-generalisability (single-surgeon, single-centre)
Conclusions
• There is a lower incidence of PPM in patients receiving
CM-TH vs CM-St (MD -32%).
• The Carbomedics Top Hat aortic prosthesis is safe,
with excellent long-term outcomes, comparable to that
of other mechanical valves.
Thank you. [email protected]
attendance and this presentation supported by: