The economic value of INTUITY in aortic valve replacement

Figures & data

Figure 1. Model scaffold—clinical outcomes. *The MISAVR and CAVR cohorts have the same clinical outcomes as the MIS-RDAVR arm. MIS-RDAVR: minimally invasive rapid deployment aortic valve replacement; MISAVR: minimally invasive aortic valve replacement; CAVR: conventional aortic valve replacement, TIA: transient ischemic attack.

Figure 2. Model scaffold—expected cost calculations. *Costs to the hospital per episode were calculated from the Premier database. †Halpern NA, Pastores SM. Critical care medicine in the United States 2000–2005: an analysis of bed numbers, occupancy rates, payer mix, and costs. Crit Care Med. 2010;38: 65–71. ‡Kaiser Family Foundation. Hospital Adjusted Expenses per Inpatient Day; 2014. Available at: http://kff.org/other/state-indicator/expenses-per-inpatient-day/.

Table 1. Best evidence literature review summary for isolated AVR.

	MISAVR		CAVR
	Range	Study references	Range	Study references
Adverse events (%)
Endocarditis	0–4.9	^24^,^25	0.4–4.9	^24^,^25
Renal complications	0–6	^24–33	0–16.7	^24–34
Stroke	0–3.57	^24^,^25^,^27–32^,^35–43	0–7.23	^24^,^25^,^27–32^,^34–43
TIA	0.5–3	^30^,^37^,^44	0.5–2	^30^,^37^,^44
Re-operation	0–12.5	^26^,^28^,^30–33^,^36–41^,^43–48	0–16.6	^26^,^28–33^,^36–48
Post-operation wound infection	0–9.9	^24–26^,^28–30^,^33^,^35^,^37–40^,^43^,^44^,^46–50	0–14.3	^24–26^,^28–30^,^33–35^,^37–40^,^43^,^44^,^46–50
Mortality rate (%)
30-day mortality	0–4	^25^,^28^,^32^,^38^,^40^,^41^,^47	1–4.9	^25^,^28^,^32^,^34^,^38^,^40^,^41^,^47
Utilization measures
Operating room (min)	153–294.6	^26^,^27^,^32^,^40^,^45^,^48–51	146.4–286.9	^26^,^27^,^32^,^34^,^40^,^45^,^48–51
CCT (min)	33.6–103	^24–30^,^32^,^33^,^37–53	33.5–89.5	^24–30^,^32–34^,^37–53
ICU stay (days)	0.28–3.03	^24^,^26^,^28^,^30–32^,^35^,^36^,^40^,^41^,^44–51^,^54	0.92–5.66	^24^,^26^,^28^,^30–32^,^35^,^36^,^40^,^41^,^44–51^,^54
Hospital ward stay (days)	5–14.7	^24^,^25^,^28^,^30^,^35^,^36^,^40^,^41^,^44–51^,^54	6–17.7	^24^,^25^,^30^,^35^,^36^,^40^,^41^,^44–51^,^54

MISAVR, minimally invasive aortic valve replacement; CAVR, conventional aortic valve replacement; TIA, transient ischemic attack; CCT, cross clamp time; ICU, intensive care unit.

Table 2. Adverse events, mortality, and utilization, by procedure type.

	MIS-RDAVR*	MISAVR†	CAVR†
Adverse event rates (%)
Endocarditis	0	0.3 ± 0.5	1.2 ± 1.1
Renal complications	3.4	2.6 ± 1.6	4.3 ± 2.1
Stroke	2.6	1.5 ± 1.2	2.1 ± 1.4
TIA	0.4	1.3 ± 1.2	0.8 ± 0.9
Re-operation	0	3.5 ± 1.9	4.0 ± 2.0
Post-operation wound infection	0.8	1.2 ± 1.1	2.7 ± 1.6
Mortality rate (%)
30-day mortality	0.4	2.2 ± 1.5	2.8 ± 1.7
Utilization measures
Operating room (min)	191.3	203.7 ± 13.4	198.4 ± 14.2
Operating room CCT (min)	63.2	73.4 ± 8.6	68.4 ± 8.3
ICU days	2.6	1.8 ± 1.3	2.5 ± 1.6
Hospital ward days	6.6	8.7 ± 3.0	9.9 ± 3.1

* Source: TRANSFORM trial, isolated AVR, Edwards INTUITY Elite Valve System.

† Sample-size weighted mean and standard deviation estimates.

MIS-RDAVR, minimally invasive rapid deployment aortic valve replacement; MISAVR, minimally invasive aortic valve replacement; CAVR, conventional aortic valve replacement; TIA, transient ischemic attack; CCT, cross clamp time; ICU, intensive care unit.

Figure 3. (a) MIS-RDAVR vs MISAVR 1-way and (b) MIS-RDAVR vs CAVR 1-way sensitivity analysis tornado diagram. MIS-RDAVR, Edwards INTUITY Elite™ minimally invasive rapid deployment aortic valve replacement; MISAVR, minimally invasive aortic valve replacement; CAVR, conventional aortic valve replacement; ICU, intensive care unit; OR, operating room; TIA, transient ischemic attack; ICER, incremental cost-effectiveness ratios.

Table 3. Expected costs and effectiveness, by procedure type.

Per patient	MIS-RDAVR*	MISAVR	CAVR
Expected costs	$41,747	$37,187	$44,368
Expected benefits: Life years gained
vs MISAVR	0.199
vs CAVR	0.265

* Incremental cost of EIE valve was assumed to be $6,000.

MIS-RDAVR, Edwards INTUITY Elite™ minimally invasive rapid deployment aortic valve replacement; MISAVR, minimally invasive aortic valve replacement; CAVR, conventional aortic valve replacement.

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