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. 2020 Nov 2;20(14):1–148.

Table 2:

Reasons for Withdrawal

Author, Year N (TAVI/SAVR) Patients Not Randomized, N (%) Procedure Not Attempted, n (%) Procedure Attempted but Valve Not Implanted, n (%) Withdrawal After Implantation Procedure, n (%)
Mack et al, 201918 1,000 (503/497)

PARTNER 3		 520 (34.2)

Reasons:

  • Anatomic exclusion (n = 308)

  • Medical exclusion criteria (n = 89)

  • Other exclusion criteria (n = 38)

  • Incomplete screening (n = 85)

 TAVI: 7 (1.4)
SAVR: 43 (8.7)

Reasons:

Ineligible
TAVI: 1 (0.2)
SAVR: 8 (1.6)

Consent withdrawn
TAVI: 6 (1.2)
SAVR: 35 (7.0)a 		TAVI: 1 (0.2)—converted to SAVR
SAVR: 1 (0.2)—procedure aborted		 Patient withdrawal or loss to follow-up
TAVI: 1 (0.2)
SAVR: 16 (3.5)
Popma et al, 201917 1,468 (734/734)

Evolut LRT		 255 (14.7)

Reasons:

  • Not approved by Screening Committeeb (n = 231)

  • Did not meet eligibility criteria (n = 4)

  • Deferred for more information (n = 3)

  • Died or lost to follow-up (n = 2)

 TAVI: 13 (1.8)
SAVR: 53 (7.2)

Reasons:

Ineligible
TAVI: 1 (0.1)
SAVR: 4 (0.5)

Consent withdrawn
TAVI: 8 (1.1)
SAVR: 33 (4.5)

Withdrawn by physician
TAVI: 1 (0.1)
SAVR: 12 (1.6)

Death
TAVI: 0
SAVR: 1 (0.1)

Lost to follow-up
TAVI: 0
SAVR: 2 (0.3)

Pending procedure
TAVI: 2 (0.3)
SAVR: 1 (0.1)		 TAVI: 4 (0.5)—underwent surgery
SAVR: 2 (0.3)—underwent TAVI (1), valve not implanted (1)		 Patient withdrawal or loss to follow-up
TAVI: 9 (1.2)
SAVR: 27 (3.7)

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

a

Decided not to undergo surgery or to undergo surgery at a nontrial hospital.

b

Aortic dimensions outside of the sizing guidelines (n = 60), predicted risk of mortality was outside of the protocol criteria (n = 6), bicuspid aortic valve (n = 138), prohibitive left ventricular outflow tract calcification (n = 18), anatomy unsuited for TAVI access (n = 1), other reasons (n = 2). Patients could have had multiple reasons for disapproval.