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Outcomes and costs of concomitant aortic valve
replacements associated with a new sutureless and collapsed
valve in Italy, France, Germany, and UK
Lorenzo Pradelli, AdRes HE&OR Orietta Zaniolo, AdRes HE&OR Stefano Giardina, Sorin Group Marco Ranucci, IRCCS San Donato (Milano)
Background 2
Aortic valve replacement (AVR) is the most common heart valve
operation and accounts for a majority of all valve surgeries performed
in the elderly;
Cross-clamping times (CCTs) are an independent risk factor for worse
outcomes;
Perceval S is a new valve with a collapsed profile, which eases
positioning, and which is implanted without need for suturing: these
features permit a very consistent reduction of CCTs.
Objective 3
To perform an economic evaluation of
the consequences of such features,
through the construction, validation,
and analysis of an ad hoc simulation
model
Input
Cross clamp time
Technique
Output
Cross clamp dependent outcome
CCT-independent
outcome
Cost
Treatment + outcome related
complication cost
Sutureless or
traditional valves
Full Sternotomy
Perceval cost model: Graphical schema
Identification of outcome CCT-dependency
significant OR for EuroScore > 6
CCT-zone associated RRs 6
ORs reported by al-Sarraf 2010 were transformed into RR distributions with the following formula:
)*(1 ORRcRc
ORRR
RRs CCT 60-90 min vs < 60 min RRs CCT > 90 min vs < 60 min
Outcome mean 2.5% 97.5% mean 2.5% 97.5%
In-hospital mortality 3.00 1.39 6.22 4.43 1.87 9.97
H LOS 1.20 0.90 1.50 2.30 1.60 3.40
ICU stay 1.30 1.00 1.60 3.00 2.00 4.60
Renal complications 1.54 1.00 2.37 2.05 1.19 3.52
Blood transfusion 1.05 0.94 1.23 1.60 1.36 1.77
Ventilation time 1.47 0.81 2.44 3.42 1.92 5.65
Estimation of outcome distributions for CCT < 60 min
7
Distributions of rates and times for patients with CCTs < 60 min were estimated in WinBugs by decomposing overall observed values, using the RRs previously reported and the trial-reported distributions of CCTs for that value, according to the general formula:
Qobs = QlowCCT × %lowCCT +
QlowCCT × RRmediumCCT × %mediumCCT +
QlowCCT × RRhighCCT × %highCCT
Data for these calculations derived from:
Sharony, 2003 HLOS, Renal complication rate, Re-operation for bleeding
DeSmet, 2004: ICULOS, Blood loss during operation and in ICU
Bakir, 2006 : Ventilation time
Baseline outcome rates 8
Values for CCT < 60 min
Mean (SD)
H LOS (days) 10.5 12.4
ICU LOS (days) 1.6 2.0
Blood loss in OP (mL) 266 66
Blood loss in ICU (mL) 359 83
Ventilator days 1.0 3.7
Mortality 3.9%
Incident dialysis 1.2%
Re-operation for bleeding 4.4%
CCT by alternative 9
Strategy CCTs (min) CCT zones Source
Mean ± SD < 60 60-90 > 90
Traditional - FS 98 ± 31 10% 34% 56% McClure
Perceval - FS 44 ± 13 87% 12% 1% Folliguet
The distributions of CCTs for each alternative were taken from: Perceval S (FS-concomitant): Folliguet 2012
Traditional valve in FS – isolated and MiS : Glauber 2012 (CCT in MiS and FS – isolated w/Perceval ~ Folliguet) -> bridge
Traditional valve in FS – concomitant: McClure 2010 (CCT in FS- isolated ~ Glauber)
Prediction of outcomes – patient-level
10
Example: HLOS in patient with sutured valve (1 of 10,000 Winbugs estimates)
Step 2: CCT
Outcome FS < 60 min
(mean +/- SD)
Mean (95%CI)
RR CCT 60-90 min
Mean (95%CI)
RR CCT >90 min
H LOS (days) 10.5 ± 12.4 1.20 (0.90 – 1.50) 2.30 (1.60 – 3.40)
Step 3: RR = 1.42 Step 1: Baseline = 72 min = 13 days
Step 4: Individual outcome 13×1.42 = 18.5 days
1.63%
4.81%
3.23%
1.59%
4.76%
3.17%
00%
01%
02%
03%
04%
05%
06%
RENAL Sharony REOP Sharony SEPSIS Sharony
Internal validation: rates
Predicted FS
Observed FS
13.9
2.3
1.6
14.0
2.3
1.6
0,0
2,0
4,0
6,0
8,0
10,0
12,0
14,0
16,0
stay Sharony iculos De Smet VENTTIME Bakir
Internal validation: times
Predicted FS
Observed FS
Cost structure 13
For each strategy, the total cost is calculated as
follows:
Where
ONSCOMPLICATISTAYHOSPSURGERYTOTAL CostCostCostCost .
ICUICUWARDWARDSTAYHOSP DailyCostLOSDailyCostLOSCost **.
Unit costs/1 14
The hospital cost perspective was adopted for all health care resources used during the index hospitalization
Published studies and official tariffs were used
Unit costs/2 15
Parameters Italy (€) France (€) Germany (€) UK (£)
Minute of OR (incl. personnel)
31.1 37.89 29.79 29.44
Ward day 412 445 448 372
ICU day 1,110 1,328 1,142 1,704
Sepsis episode 2,061 3,723 3,264 7,769
Dialysis H day 311 154 74 68
VAP episode 8,096 12,818 4,664 6,686
Rehabilitation day
261 262 290 293
RBC unit 153 184 106 173
Results 16
V/SA Surgery Ward Rehab ICU Comp.ns Total Delta*
Ital
y (€
) Tr 8,011 6,072 4,365 3,925 431 22,800 (6,653) 6,060 (58)
P 6,294 3,816 2,420 3,925 285 16,740 (2,408)
Fran
ce
(€)
Tr 9,572 6,557 5,226 3,930 493 25,780 (7,823) 6,970 (68)
P 7,490 4,121 2,897 3,930 372 18,810 (2,860)
Ge
rman
y
(€)
Tr 7,709 6,614 4,492 4,359 295 23,470 (7,823)
6,170 (60) P 6,063 4,156 2,491 4,359 231 17,300 (2,860)
UK
(£
) Tr 7,584 5,481 6,703 4,398 536 24,700 (7,823) 6,750 (78)
P 5,951 3,444 3,716 4,398 443 17,950 (2,860)
One-way sensitivity 17
15500 17500 19500 21500 23500 25500
Ventilation time/VAP cost
Sepsis rate/cost
Dialysis rate/cost
Blood loss/cost
Reoperation rate
Rehab rate/cost
ICU LOS/unit cost
H LOS/unit cost
Surgery cost/minute
Cross-clamp time
Total cost - Trd, FS, Concomitant (€)
Ventilation time/VAP cost
Sepsis rate/cost
Dialysis rate/cost
Blood loss/cost
Reoperation rate
Cross-clamp time
ICU LOS/unit cost
H LOS/unit cost
Rehab rate/cost
Surgery cost/minute
Total cost - Perc, FS, Concomitant (€)
low high
Conclusions 18
Results of the present analysis indicate that use of Perceval S allows important savings in the most relevant AVR cost items.
This cost saving is found in reduced CCTs, which lead to shorter stays in the ICU and in the hospital as a whole, due a lower occurrence of complications.
Thank you
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