A Systematic Review and Statistical Analysis of Factors Influencing the Cost-Effectiveness of Transcatheter Aortic Valve Implantation for Symptomatic Severe Aortic Stenosis

Figures & data

Figure 1 PRSIMA flow chart (HTA: Health Technology Assessment).

Table 1 Variables Included in Quantitative Analyses

Procedural	Methodological
1) Risk group (inoperable, high, intermediate, low)	4) Time horizon (Less than two years, two to ten years, lifetime)
2) Access route (percent transfemoral. For descriptive statistics this is categorised into 0% transfemoral, 70–85% transfemoral, 85–99% transfemoral and 100% transfemoral. For quantitative analyses it is a continuous variable)	5) Discount rate: costs
3) Device type (latest generation vs older generations; balloon-expandable vs self-expandable)	6) Discount rate: benefits
	7) Model type (if a health economic model was used or not)
	8) If base-case results are derived from a deterministic or a probabilistic analysis

Table 2 Overview of Included Analyses

Author, Year	Study Type	Country	Pop-ulation	Key Evidence Source(s)	Inter-vention	Comp-arator	Access route	Time Horizon (Years)	Discount Rate (QALYs, Costs)	Model Type	Inc. Costs	Inc. QALYs	ICER
Watt 2012 [43]	EM	UK	Inop.	PARTNER 1B	Older BE	MM	TF	10	0.035, 0.035	Markov	£25,200	1.56	£16,200
HQO 2012 [44]	HTA	CAN	Inop.	PARTNER 1B	Older BE	MM	TF	20	NR, 0.05	DT + Markov	$31,203	0.638	$48,912
Reynolds 2012a [45]	TE	USA	Inop.	PARTNER 1B	Older BE	MM	TF	2.5	0.03, 0.03	No model	$79,837	1.59	$50,212
Doble 2013 [46]	EM	CAN	Inop.	PARTNER 1A, PARTNER 1B	Older BE	MM	TF	20	NR, 0.05	DT + Markov	$31,028	0.6	$51,324
Hancock-Howard 2013 [47]	EM	CAN	Inop.	PARTNER 1B	Older BE	MM	TF	3	0.05, 0.05	DT	$15,687	0.488	$32,170
Murphy 2013 [48]	EM	UK	Inop.	PARTNER 1B	Older BE	MM	TF	Lifetime	NR, NR	DT + Markov	£15,885	0.44	£35,956
Simons 2013 [49]	EM	USA	Inop.	PARTNER 1B	Older BE	MM	TF	Lifetime	0.03, 0.03	Markov	$85,600	0.7	$116,500
Brecker 2014 [50]	EM	UK	Inop.	PARTNER 1B, ADVANCE	Older SE	MM	TF, direct, SC	5	0.035, 0.035	Markov	£22,009	1.24	£17,718
Brecker 2014 [50]	EM	UK	Inop.	PARTNER 1B, ADVANCE	Older SE	MM	TF, direct, SC	5	0.035, 0.035	Markov	£21,038	1.51	£13,943
MSAC 2016 [36]	HTA	AUS	Inop.	PARTNER 1B	Older BE	MM	TF	5	NR, NR	NR	$8,777	0.75	$11,708
HAS 2017 [51]	EM	FRA	Inop.	FRANCE 2 registry	Older SE	MM	TF	5	0.04, 0.04	DT + Markov	€21,207	1.023	€20,738
HAS 2021 [35]	EM	FRA	Inop.	FRANCE 2 registry	Older BE	MM	TF	5	0.04, 0.04	DT + Markov	€18,090	0.163	€15,552
Kodera 2018 [52]	EM	JPN	Inop.	PARTNER 2A	Older BE	MM	TF, TA	10	0.02, 0.02	Markov	¥6,375,062	1.75	¥3,918,808
Inoue 2020 [53]	EM	JPN	Inop.	Literature review	Older BE	MM	TF	Lifetime	0.02, 0.02	DT + Markov	¥1,556,749	1.16	¥1,337,525
Lorenzoni 2021 [54]	EM	IT	Inop.	PARTNER 2A	Latest BE	MM	NR	15	0.03, 0.03	Markov	€11,920	1.18	€10,133
Pinar 2021 [55]	EM	SPN	Inop.	PARTNER 1B	Latest BE	MM	TF	15	0.03, 0.03	Markov	€12,967	1.31	€9,748
HQO 2012 [44]	HTA	CAN	High	PARTNER 1A	Older BE	SAVR	TF, TA	20	NR, 0.05	DT + Markov	$11,153	−0.102	TAVI dominated
Gada 2012a [56]	EM	USA	High	Registry data (not named)	Older BE	SAVR	NR	Lifetime	0.05, 0.05	Markov	$3164	0.06	$52,773.00
Gada 2012b [57]	EM	USA	High	Registry data (not named)	Older BE	SAVR	TA	Lifetime	0.05, 0.05	Markov	$100	−0.04	TAVI dominated
Reynolds 2012b [45]	TE	USA	High	PARTNER 1A	Older BE	SAVR	TF	1	0.03, 0.03	No model	-$1250	0.068	TAVI dominant
Reynolds 2012b [45]	TE	USA	High	PARTNER 1A	Older BE	SAVR	TA	1	0.03, 0.03	No model	$9906	−0.07	TAVI dominated
Reynolds 2012b [45]	TE	USA	High	PARTNER 1A	Older BE	SAVR	TF, TA	1	0.03, 0.03	No model	$2070	0.027	$76,877
Doble 2013 [46]	EM	CAN	High	PARTNER 1A, PARTNER 1B	Older BE	SAVR	TF, TA	20	NR, 0.05	DT + Markov	$11,153	−0.102	TAVI dominated
Fairbairn 2013 [58]	EM	UK	High	PARTNER 1A	Older BE	SAVR	TF, TA	10	0.035, 0.035	DT + Markov	-£1350	0.063	TAVI dominant
Osteba 2014 [59]	EM	SPN	High	PARTNER 1A	Older BE	SAVR	TF, TA	Lifetime	0.03, 0.03	DT + Markov	€9,072	0.08	€119,575
HTA Ontario 2016 [33]	HTA	CAN	High	CoreValve High Risk Trial	Older SE	SAVR	All	5	0.05, 0.05	Markov	$9,412	0.181	$51,988
MSAC 2016 [36]	HTA	AUS	High	PARTNER 1A	Older BE	SAVR	TF	5	NR, NR	NR	$3,987	0.26	$15,541
Reynolds 2016 [60]	TE	USA	High	CoreValve High Risk Trial	Older SE	SAVR	TF, AX, direct	Lifetime	0.03, 0.03	No model	$17,849	0.324	$55,090
Geisler 2017 [61]	EM	NL	High	CoreValve High Risk Trial	Older SE	SAVR	TA	Lifetime	0.04, 0.015	DT + Markov	€9,048	0.41	€21,946
HAS 2017 [51]	EM	FRA	High	CoreValve High Risk Trial	Older SE	SAVR	TF, AX, direct	5	0.04, 0.04	DT + Markov	€7,823	0.146	€53,754
Tarride 2019 [62]	EM	CAN	High	PARTNER 2A	Latest BE	SAVR	TF, TA, direct	15	0.015, 0.015	Markov	$7,362	0.43	$17,237.00
Inoue 2020 [53]	EM	JPN	High	Literature review	Older BE	SAVR	TF	Lifetime	0.02, 0.02	DT + Markov	¥6,837,595	1.98	¥3,460,810
Lorenzoni 2021[54]	EM	IT	High	PARTNER 2A	Latest BE	SAVR	Not reported	15	0.03, 0.03	Markov	€3,831	0.34	€11,209
Pinar 2021[55]	EM	SPN	High	PARTNER 1A	Latest BE	SAVR	TF, TA	15	0.03, 0.03	Markov	€2,155	0.39	€4,796
Ferreira-González 2013 [63]	EM	SPN	High or inop.	SOURCE Registry	Older BE	MM	TA	3	0.03, 0.03	DT	€14,208	0.5	€28,003
Ferreira-González 2013 [63]	EM	SPN	High or inop.	SOURCE Registry	Older BE	MM	TF	3	0.03, 0.03	DT	€12,586	0.64	€19,499
HTA UK 2013 [64]	HTA	UK	High or inop.	PARTNER 1	Older BE	MM*	TF	25	0.035, 0.035	DT	£22,528	1.62	£13,900
Kodera 2018 [52]	EM	JPN	Int.	PARTNER 1B	Older BE	SAVR	TF	10	0.02, 0.02	Markov	¥1,723,516	0.22	¥7,523,821
Tam 2018a [65]	EM	CAN	Int.	PARTNER 2A	Older BE	SAVR	TF, TA, direct	Lifetime	0.015, 0.015	Markov	$10,548	0.23	$46,083
Tam 2018b [66]	EM	CAN	Int.	SURTAVI	Older SE, latest SE	SAVR	TF, direct, SC	Lifetime	0.015, 0.015	Markov	$11,305	0.15	$76,736
Baron 2019 [67]	TE	USA	Int.	PARTNER 2A	Older BE	SAVR	TF, TA, direct	Lifetime	0.03, 0.03	No model	-$7949	0.15	TAVI dominant
Baron 2019 [67]	TE	USA	Int.	PARTNER 2 S3	Latest BE	SAVR	TF, TA, direct	Lifetime	0.03, 0.03	No model	-$9692	0.27	TAVI dominant
Baron 2019[67]	TE	USA	Int.	PARTNER 2A	Older BE	SAVR	TF	Lifetime	0.03, 0.03	No model	-$11,738	0.3	TAVI dominant
Baron 2019[67]	TE	USA	Int.	PARTNER 2A	Older BE	SAVR	TA	Lifetime	0.03, 0.03	No model	$4,489	−0.35	TAVI dominated
Goodall 2019 [68]	EM	FRA	Int.	PARTNER 2 S3	Latest BE	SAVR	TF, TA, direct	15	0.04, 0.04	Markov	-€439	0.41	TAVI dominant
HIQA 2019 [32]	HTA	ROI	Int.	PARTNER 2A	Older BE	SAVR	TF, TA, direct	15	0.04, 0.04	Markov	Not reported	Not reported	TAVI dominant
HIS 2019 [34]	HTA	SCO	Int.	PARTNER 2A	Older BE	SAVR	TF, TA, direct	Lifetime	0.035, 0.035	Markov	£12,944	0.13	£98,965
NIPH 2019 [69]	HTA	NOR	Int.	PARTNER 2A	Older BE	SAVR	TF, TA, direct	2	0.04, 0.04	Markov	NOK 71,000	0.07	NOK 1,040,000
Tarride 2019 [62]	EM	CAN	Int.	PARTNER 2A	Latest BE	SAVR	TF, TA, direct	15	0.015, 0.015	Markov	$13,473	0.48	$28,154
Zhou 2019 [70]	EM	AUS	Int.	PARTNER 2 S3	Latest BE	SAVR	All	Lifetime	0.05, 0.05	Markov	-$9,629	0.31	TAVI dominant
HTW 2020 [71]	HTA	WAL	Int.	PARTNER 2A	Older BE	SAVR	TF, TA, direct	Lifetime	0.035, 0.035	Markov	£9,145	0.1	£94,512
Lorenzoni 2021 [54]	EM	IT	Int.	PARTNER 2 S3	Latest BE	SAVR	NR	15	0.03, 0.03	Markov	€3,593	0.43	€8,338
Pinar 2021[55]	EM	SPN	Int.	PARTNER 2 S3	Latest BE	SAVR	TF, TA	15	0.03, 0.03	Markov	€3,537	0.44	€,7497
Geisler 2019 [72]	EM	DK	Low	NOTION	Older SE	SAVR	TF, SC	Lifetime	0.04, 0.015	DT + Markov	DKK 64,561	0.09	DKK 696,664
HIQA 2019 [32]	HTA	ROI	Low	PARTNER 3	Latest BE	SAVR	TF	15	0.04, 0.04	Markov	Not reported	Not reported	TAVI dominant
Tam 2020 [73]	EM	CAN	Low	PARTNER 3	Latest BE	SAVR	TF	Lifetime	0.015, 0.015	Markov	$5,077	0.085	$59,641
Tam 2020 [73]	EM	CAN	Low	Evolut low-risk	Latest SE	SAVR	TF	Lifetime	0.015, 0.015	Markov	$2,747	0.099	$27,196
Gilard 2021 [74]	EM	FRA	Low	PARTNER 3	Latest BE	SAVR	TF	Lifetime	0.025, 0.025	DT + Markov	-€12,742	0.89	TAVI dominant
HAS 2021 [75]	EM	FRA	Low	Evolut low-risk	Latest SE	SAVR	TF	15	0.025, 0.025	Markov	€708	0.12	€5,893
NIPH 2021 [37]	HTA	NOR	Low	PARTNER 3	Latest BE	SAVR	TF	15	0.04, 0.04	Markov	NOK −35,000	0.05	TAVI dominant
Zhou 2021 [76]	EM	AUS	Low	PARTNER 3	Latest BE	SAVR	TF	Lifetime	0.05, 0.05	Markov	$702.00	0.2	$3,521
Zhou 2021 [76]	EM	AUS	Low	Evolut low-risk	Latest SE	SAVR	TF	Lifetime	0.05, 0.05	Markov	-$507	0.08	TAVI dominant
HAS 2021 SAPIEN 3 [35]	EM	FRA	Low	PARTNER 3	Latest BE	SAVR	TF	15	0.025, 0.025	DT + Markov	-€7,737	0.64	TAVI dominant
Kuntjoro 2020 [77]	EM	SG	Int. or low	PARTNER 2A	Older BE	SAVR	TF	8	0.03, 0.03	DT + Markov	$5,852	0.21	$33,833
Kuntjoro 2020 [77]	EM	SG	Int. or low	PARTNER 2 S3	Latest BE	SAVR	TF	8	0.03, 0.03	DT + Markov	Not reported	Not reported	$21,732

Notes: *Actual comparator is “TAVI not available”. Based on the description given, this appeared to be treated as medical management.

Abbreviations: AUS, Australia; AX, Axillary; BE, Balloon-Expandable; CAN, Canada; DK, Denmark; DT, Decision Tree; EM, Economic model; Inc., Incremental; Inop., Inoperable; Int., Intermediate; IT, Italy; JPN, Japan; MM, Medical management; NL, Netherlands; NOR, Norway; NR, Not reported; ROI, Republic of Ireland; SC, Subclavian; SCO, Scotland; SE, Self-Expandable; SG, Singapore; SPN, Spain; TE, Trial evaluation; TA, Transapical; TF, Transfemoral; UK, United Kingdom; US, United States; WAL, Wales.

Table 3 Univariate Associations Between Variables and the Probability That TAVI is Found Cost-Effective or Dominant

		Count of Analyses		TAVI Cost-Effective		TAVI Dominant
		N	% of All Studies	N	% of Row	N	% of Row
Region	US	12	18%	6	50%	4	33%
	Canada	12	18%	8	67%	0	0%
	Europe	30	46%	24	80%	7	23%
	Rest of the world	11	17%	10	91%	2	18%
Population/Indication	Inoperable	16	25%	14	88%	0	0%
	High Risk	18	28%	9	50%	2	11%
	Intermediate Risk	16	25%	10	63%	6	38%
	Low Risk	10	15%	10	100%	5	50%
	Mixed	5	8%	5	100%	0	0%
Valve Type	Balloon Expandable	53	82%	40	75%	12	23%
	Older (SAPIEN / SAPIEN XT)	35	54%	22	63%	5	14%
	Latest (SAPIEN 3)	18	28%	18	100%	7	39%
	Self Expandable	12	18%	8	67%	1	8%
	Older (CoreValve)	8	12%	5	63%	0	0%
	Latest (Evolut)	2	3%	2	100%	1	50%
	Mixed	2	3%	1	50%	0	0%
TAVI approach	Transapical	5	8%	2	40%	0	0%
	Mixed (70% - 85% transfemoral)	20	31%	10	50%	3	15%
	Mixed (85% - 99% transfemoral)	9	14%	8	89%	3	33%
	Transfemoral	30	46%	27	90%	7	23%
	Not reported	1	2%	1	100%	0	0%
Study type	Economic model	44	68%	36	82%	6	14%
	HTA	12	18%	7	58%	3	25%
	Trial evaluation (no model)	9	14%	5	56%	4	44%
Model type	Markov model	32	49%	24	75%	6	19%
	Decision tree	4	6%	4	100%	0	0%
	Decision tree + Markov model	18	28%	13	72%	3	17%
	No model	9	14%	5	56%	4	44%
	Not reported	2	3%	2	100%	0	0%
Time Horizon	Lifetime	47	72%	35	74%	12	26%
	2–10 years	15	23%	12	80%	0	0%
	< 2 years	3	5%	1	33%	1	33%
Discount Rate- Benefits	< 3%	15	23%	11	85%	2	15%
	≥ 3%	47	72%	33	73%	11	24%
	Not reported	3	5%	4	57%	0	0%
Discount Rate- Costs	< 3%	13	20%	2	13%	2	13%
	≥ 3%	45	69%	11	23%	11	23%
	Not reported	7	11%	4	6%	0	0%
Base case methods	Deterministic mean	32	49%	25	78%	6	19%
	Probabilistic mean	22	34%	16	73%	3	14%
	No model	9	14%	5	56%	4	44%
	Not reported	2	3%	2	100%	0	0%

Abbreviations: HTA, Health Technology Assessment; TAVI, Transcatheter Aortic Valve Implantation.

Figure 2 Relative importance of clinical variables (TAVI: transcatheter aortic valve implantation). Results are shown relative to the most important factor (indexed to 1). Positive values indicate more likely to be found cost-effective, negative values less likely.

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