A Canadian cost-effectiveness analysis of SAPIEN 3 transcatheter aortic valve implantation compared with surgery, in intermediate and high-risk severe aortic stenosis patients

Figures & data

Figure 1 Graphical representation of the model structure.

Abbreviation: NYHA, New York Heart Association.

Table 1 Clinical outcomes for intermediate-risk patients

Outcomes	30-Day outcomes		1-Year outcomes
	TAVI using SAPIEN 3	SAVR	TAVI using SAPIEN 3	SAVR
Mortality	1.03%	3.53%	8.81%	12.83%
Major stroke	1.10%	4.29%	2.38%	5.78%
Transient ischemic attack	0.46%	0.41%	1.92%	1.79%
Atrial fibrillation	5.42%	27.08%	6.34%	27.08%
Renal replacement therapy	0.46%	3.16%	0.46%	5.26%
Myocardial infarction	0.28%	1.84%	0.28%	3.33%
New pacemaker	10.02%	6.95%	10.56%	8.74%
Major bleeding	10.57%	31.57%	11.02%	36.98%
Repeat hospitalization	4.87%	7.05%	13.03%	17.81%
Heart failure hospitalization	1.74%	1.74%	6.90%	9.42%
Endocarditis	0.19%	0.00%	0.73%	0.31%
Redo with TAVI	0.00%	0.00%	0.27%	1.82%
Redo with SAVR	0.00%	0.00%	0.73%	0.44%

Abbreviations: TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement.

Table 2 Clinical outcomes for high-risk patients

Outcomes	30-Day outcomes		1-Year outcomes
	TAVI using SAPIEN 3	SAVR	TAVI using SAPIEN 3	SAVR
Mortality	3.11%	5.68%	11.36%	20.01%
Major stroke	1.26%	1.21%	2.79%	1.55%
Transient ischemic attack	0.76%	0.30%	2.55%	1.28%
Atrial fibrillation	5.80%	17.18%	8.88%	17.18%
Renal replacement therapy	1.01%	4.22%	1.01%	5.86%
Myocardial infarction	0.50%	0.30%	1.99%	0.30%
New pacemaker	10.60%	4.22%	12.64%	4.85%
Major bleeding	13.37%	23.20%	16.95%	27.87%
Repeat hospitalization	6.81%	5.42%	18.58%	17.83%
Heart failure hospitalization	3.02%	3.02%	10.79%	13.09%
Endocarditis	0.25%	0.00%	1.28%	0.63%
Redo with TAVI	0.00%	0.00%	0.26%	0.26%
Redo with SAVR	0.00%	0.00%	2.92%	0.00%

Abbreviations: TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement.

Table 3 Procedural cost by patient risk population*

	Intermediate risk		High risk		Combined population (sensitivity analysis)**
	TAVI using SAPIEN 3	SAVR	TAVI using SAPIEN 3	SAVR	TAVI using SAPIEN 3	SAVR
Device costs	$25,000	$6,000	$25,000	$6,000	$25,000	$6,000
Non-device costs (ie hospitalizations)	$34,395	$37,611	$45,497	$59,507	$39,466	$44,142
Total costs	$59,395	$43,611	$70,497	$65,507	$64,466	$50,142

Notes: *Surgical risk categories based on logistic EuroScore 1 values. Non-device costs (ie hospitalization costs) were derived from the Canadian Institute for Health Information (CIHI) admission data from April 1, 2014 to March 31, 2016. **Independent of surgical risk status.

Abbreviations: TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement.

Table 4 Costs and dis-utilities applied to model events

Event	Value	Source
Costs
Stroke (ischemic or hemorrhagic)
First year	$57,024	Mittman^Citation33
2nd year and beyond	$7,085	Blackhouse^Citation34
Transient ischemic attack	$3,716	CIHI PCE^Citation22 CMG029
Major bleeding (not cerebral)	$4,700	CIHI PCE^Citation22 CMG187
Pacemaker implant	$12,177	CIHI PCE^Citation22 CMG187
Myocardial infarction	$7,524	CIHI PCE^Citation22 CMG 193,194
Acute onset atrial fibrillation	$4,555	CIHI PCE^Citation22 CMG201,202
Other hospitalization (not included in the above)	$6,098	CIHI average hospitalization cost^Citation21
Heart filure hospitalization	$7,426	CIHI PCE^Citation22 CMG195,196
Renal failure needing replacement therapy	$743	Alberta Health^Citation23 C471,C472
Endocarditis	$35,084	Alberta Health^Citation23 CMG+219
Balloon valvuloplasty	$29,304	Alberta Health^Citation23 CMG+178
Vascular complication (not included in bleeding)	$10,320	Alberta Health^Citation23 CMG+213
Dis-utilities (used in sensitivity analysis)
Stroke	0.68 (utility weight)	Tengs^Citation26
Transient ischemic attack	0.033	Sullivan^Citation35
Major bleeding (not cerebral)	0.181	Sullivan^Citation35
Vascular complication (not included in Bleeding)	0.06	Fairbairn^Citation28
Heart failure hospitalization	0.1167	Sullivan^Citation35
Acute onset atrial fibrillation	0.0384	Sullivan^Citation35
Renal replacement therapy	0.1104	Sullivan^Citation35
Myocardial infarction	0.0626	Sullivan^Citation35
Endocarditis	0.0289	Sullivan^Citation35

Abbreviations: CIHI PCE, Canadian Institute for Health Information patient cost estimator; CMG, case mix group.

Table 5 Base-case cost-effectiveness results

	Costs	QALYs	Incremental cost per QALY gained
Intermediate risk
TAVI using SAPIEN 3	$70,556	5.10
SAVR	$57,083	4.62
Difference	$13,473	0.48	$28,154
High risk
TAVI using SAPIEN 3	$84,348	3.57
SAVR	$76,986	3.15
Difference	$7,362	0.43	$17,237

Abbreviations: TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement; QALYs, quality-adjusted life years.

Figure 2 Cost-effectiveness acceptability curves for TAVI (SAPIEN 3) versus SAVR.

Abbreviations: TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement; QALY, quality-adjusted life year.

Table 6 One-way sensitivity analysis: TAVI using SAPIEN 3 versus SAVR

	Incremental cost per QALY gained: intermediate risk	Incremental cost per QALY gained: high risk
Base case results	$28,154	$17,237
Time horizon (base case: 15 years)
10 years	$35,505	$17,737
5 years	$65,562	$20,970
Discount rates (base case: 1.5%)
0%	$25,675	$16,667
3%	$30,699	$17,812
Initial hospitalization costs based on all patients independent of risk level (base case: different costs based on risk level)	$25,278	$38,136
SAVR costs (base case: $6,000)
$4,000	$32,334	$21,920
$8,000	$23,975	$12,554
$12,000	$15,616	$3,188
Exclude non stroke management costs (base case: included)	$28,280	$17,369
Non-device procedure costs
−20% of base case costs	$29,256	$23,065
+20% of base case costs	$27,052	$11,410
Event dis-utilities included (base case: excluded)	$18,518	$13,853

Abbreviations: TAVI, Transcatheter aortic valve implantation; QALY, quality-adjusted life year; SAVR, surgical aortic valve replacement.

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