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

Questions?