Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Who Cannot Undergo Surgery

A Technology Assessment

Jeffrey A. Tice, MD

CTAF

Recommendation

It is recommended that use of the SAPIEN transcatheter aortic valve meets CTAF TA Criterion 1 through 5 for safety, effectiveness and improvement in net health outcomes when used for the treatment of severe, symptomatic aortic stenosis in patients determined to be inoperable by a cardiac surgeon who can be treated using the transfemoral approach.

February 8, 2011

This is the first review of this technology by the California Technology Assessment Forum.

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Table 1. Severity of aortic stenosis
	Valve area, cm²	Pressure gradient, mm Hg	Jet velocity, m per second
Mild	≥ 1.5	< 25	< 3.0
Moderate	1.0 to 1.5	25 to 40	3.0 to 4.0
Severe	< 1.0	> 40	> 4.0

Post approval study	Objectives
1 Yearly follow up of patients in premarket study through five years post implant	•Describe the five-year durability and quality of life outcomes. The measure for durability will be the degree of aortic insufficiency as measure via echocardiogram Quality of life will be measure by three instruments – the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-12, and EuroQol (EQ)-5D Utilities
2 Follow up newly enrolled patients through five years post implant	•Evaluate the neurological and vascular outcomes at 30 days and annually through five years post implant. •"Assess the learning curve among surgical teams placing the device at 50 geographically disbursed sites with high, moderate and low volumes of potential patient participation. •Evaluate the composite safety and effectiveness endpoints at 30 days and annually through five years post implant.

Post approval study

Objectives

1 Yearly follow up of patients in premarket study through five years post implant

•Describe the five-year durability and quality of life outcomes. The measure for durability will be the degree of aortic insufficiency as measure via echocardiogram Quality of life will be measure by three instruments – the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-12, and EuroQol (EQ)-5D Utilities

2 Follow up newly enrolled patients through five years post implant

•Evaluate the neurological and vascular outcomes at 30 days and annually through five years post implant.
•"Assess the learning curve among surgical teams placing the device at 50 geographically disbursed sites with high, moderate and low volumes of potential patient participation.
•Evaluate the composite safety and effectiveness endpoints at 30 days and annually through five years post implant.

Table 2. Characteristics of the larger published studies of transcatheter aortic valve replacement
Study	Group	Location	N	Time frame	Valve type	Follow-up (months)	Age, years	Sex, % female	Log EuroSCORE	STS score
Uncontrolled cohorts
Grube 2008	TAVR	Sieborg,Germany	136	2005–2008	CoreValve	NR	82	58	23	9
Piazza 2008	TAVR	Multicenter	646	2007–2008	CoreValve	NR	81		23	NR
Webb 2009	TAVR	Vancouver,Canada	168	2005–2008	SAPIEN	NR	84	48	29	9
Rodes-Cabeau 2010	TAVR	Canada - 6 centers	339	2005–2009	SAPIEN	8	81	55	NR	10
Bosmans 2011	TAVR	Multicenter Belgium	328	?-2010	CoreValve, SAPIEN	NR	83	54	28	NR
D'Onofrio 2011	TAVR	Multicenter Italy	504	2008–2010	SAPIEN	9	81	61	26	11
Eltchaninoff 2011	TAVR	Multicenter France	244	2009	CoreValve, SAPIEN	1	82	43	26	19
Gurvitch 2011	TAVR	Vancouver,Canada	270	NR	SAPIEN	1	83	50	NR	10
Lefevre 2011	TAVR TF TAVR TA	Multicenter Europe	61 69	2007–2008	SAPIEN	12	82 82	61 51	26 34	11 12
Moat 2011	TAVR	Multicenter UK	870	2007–2009	CoreValve, SAPIEN	NR	82	48	19	NR
Tamburino 2011	TAVR	Multicenter Italy	663	2007–2009	CoreValve	18	81	56	23	NR
Thomas 2010, 2011	TAVR TF TAVR TA	Multicenter Europe	463 575	2007–2009	SAPIEN	12	82 81	55 56	26 29	NR
Zahn 2011	TAVR	Multicenter Germany	697	2009	CoreValve, SAPIEN		81	56	21	NR
Comparative studies
Kapadia 2009	TAVR Medical	Cleveland,Ohio	18 36	2006–2007	SAPIEN	9 6	81 83	33 53	28 25	11 13
Rajani 2010	TAVR Medical	Brighton, UK	38 47	2007–2009	CoreValve	7	83 81	45 52	24 13	NR
Randomized trials
Leon 2010	TAVR Medical	Multicenter, US, Germany, Canada	179 179	2007–2009	SAPIEN	19	83	54	28	12

Table 3. Procedural and 30 day benefits and harms of transcatheter aortic valve replacement
Study	Group	Procedural success, %	Death,%	Major Stroke,%	Major vascular complication	Pacemaker placement,%	Mod-severe aortic regurgitation, %	MI,	Tamp,%	Major bleeding,	Need for hemodialysis,%
Uncontrolled cohorts
Grube 2008	TAVR	86	12	1	NR	25	26	2	1	NR	NR
Piazza 2008	TAVR	97	8	2	2	9	NR	1	1	0	NR
Webb 2009	TAVR	94	11	4	8	5	42	1	2	12	2
Rodes-Cabeau 2010	TAVR	93	10	2	13	5	6	1	0	NR, > 1.4	3
Bosmans 2011	TAVR	97	11	5	NR	NR	NR	NR	NR	NR	NR
D'Onofrio 2011	TAVR	99	8	3	NR	5	NR	2	NR	NR	6
Eltchaninoff 2011	TAVR	98	13	4	7	12			2	NR	2
Gurvitch 2011	TAVR	95	10	3	7	6	NR	NR	2	9	3
Lefevre 2011	TAVR TF TAVR TA	96 95	8 19	3 2	28 5	2 4	NR	3 6	NR	5 12	0 6
Moat 2011	TAVR	97	7	4	6	16	14	1	NR	NR	NR
Tamburino 2011	TAVR	98	6	1	2	17	21	0	1	3	NR
Thomas 2010, 2011	TAVR TF TAVR TA	95 93	6 10	2 3	11 2	7 7	2 2	NR	NR	NR	1 7
Zahn 2011	TAVR	98	12	3	17	39	Severe AR 2.3%	1	2	NR	NR
Comparative studies
Kapadia 2009	TAVR Medical	NR NR	5% NR	0 NR	NR NR	6 NR	NR NR	0 NR	NR NR	NR NR	NR NR
Rajani 2010	TAVR Medical	NR NR	8 NR	3 NR	3 NR	34 NR	NR NR	NR NR	3 NR	NR NR	3 NR
Randomized trials
Leon 2010	TAVR Medical	97 100	5 3	5 1	16 1	3 5	12 -	0 0	NR NR	17 4	1 2

Table 4. Benefits and harms of transcatheter aortic valve replacement at one year
Study	Group	Death	Major Stroke	NYHA Heart Failure Class	Quality of life KCCQ	Quality of life SF-12
Uncontrolled cohorts
Grube 2008	TAVR	18	4	3.3 to 1.7	NR	NR
Piazza 2008	TAVR	NR	NR	NR	NR	NR
Webb 2009	TAVR	26	4	78% Class I or II	NR	NR
Rodes-Cabeau 2010	TAVR	24	NR	NR	NR	NR
Bosmans 2011	TAVR	21	NR	NR	NR	NR
D'Onofrio 2011	TAVR	19	NR	NR	NR	NR
Eltchaninoff 2011	TAVR	NR	NR	NR	NR	NR
Gurvitch 2011	TAVR	NR	NR	NR	NR	NR
Lefevre 2011	TAVR TF TAVR TA	21 51	7 10	86% Class I or II 80% Class I or II	50 to 68 50 to 77	NR
Moat 2011	TAVR	21	NR	NR	NR	NR
Tamburino 2011	TAVR	15	3	> 50% Class I or II	NR	NR
Thomas 2010, 2011	TAVR TF TAVR TA	19 28	5 5	78% Class I or II 69% Class I or II	NR	NR
Zahn 2011	TAVR	NR	NR	NR	NR	NR
Comparative studies
Kapadia 2009	TAVR Medical	~22% ~44%	NR	NR	NR	NR
Rajani 2010	TAVR Medical	~13% ~28%	NR	NR	NR	NR
Randomized trials
Leon 2010 Reynolds 2011	TAVR Medical	31 50	8 4	75% Class I or II 42% Class I or II	+32 +4	+7 +2

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