Table A16:

GRADE Evidence Profile for Comparison of TAVI Versus SAVR (Safety Outcomes)

No. of Studies (Design)	Risk of Bias	Inconsistency	Indirectness	Imprecision	Publication Bias	Upgrade Considerations	Quality
Procedural Complications
1 RCT18	No serious limitations	Cannot be evaluated	No serious limitations	Very serious limitations (−2)a	Undetected	Not applicable	⊕⊕ Low
Life-Threatening Bleeding at 30 Days
2 RCTs17,18	No serious limitations	No serious limitations	No serious limitations	No serious limitations	Undetected	Not applicable	⊕⊕⊕⊕ High
Major Vascular Complications at 30 Days
2 RCTs17,18	No serious limitations	No serious limitations	No serious limitations	Very serious limitations (−2)a	Undetected	Not applicable	⊕⊕ Low
Acute Kidney Injury at 30 Days
2 RCTs17,18	No serious limitations	No serious limitations	No serious limitations	No serious limitations	Undetected	Not applicable	⊕⊕⊕⊕ High
New-Onset Atrial Fibrillation at 30 Days
2 RCTs17,18	No serious limitations	No serious limitations	No serious limitations	No serious limitations	Undetected	Not applicable	⊕⊕⊕⊕ High
Myocardial Infarction at 30 Days
2 RCTs17,18	No serious limitations	No serious limitations	No serious limitations	Very serious limitations (−2)a	Undetected	Not applicable	⊕⊕ Low
Myocardial Infarction at 1 Year
2 RCTs17,18	No serious limitations	No serious limitations	No serious limitations	Very serious limitations (−2)a	Undetected	Not applicable	⊕⊕ Low
New Pacemaker Implantation at 30 Days, Self-Expanding Valve
1 RCT17	No serious limitations	Cannot be evaluated	No serious limitations	No serious limitations	Undetected	Not applicable	⊕⊕⊕⊕ High
New Pacemaker Implantation at 30 Days, Balloon-Expandable Valve
1 RCT18	No serious limitations	Cannot be evaluated	No serious limitations	Serious limitations (−1)b	Undetected	Not applicable	⊕⊕⊕ Moderate
New Left Bundle Branch Block at 30 Days
1 RCT18	No serious limitations	Cannot be evaluated	No serious limitations	No serious limitations	Undetected	Not applicable	⊕⊕⊕⊕ High
Moderate-to-Severe Paravalvular Aortic Valve Regurgitation at 30 Days and 1 Year
2 RCTs17,18	No serious limitations	Serious limitations (−1)c	No serious limitations	Serious limitations (−1)d	Undetected	Not applicable	⊕⊕⊕ Moderate
Moderate-to-Severe Paravalvular Aortic Valve Regurgitation at 2 Years
1 RCT17	No serious limitations	Cannot be evaluated	No serious limitations	Serious limitations (−1)e	Undetected	Not applicable	⊕⊕⊕ Moderate
Asymptomatic Valve Thrombosis at 1 Year
1 RCT18	No serious limitations	Cannot be evaluated	No serious limitations	Very serious limitations (−2)a	Undetected	Not applicable	⊕⊕ Low
Valve Thrombosis at 1 Year
1 RCT17	No serious limitations	Cannot be evaluated	No serious limitations	Very serious limitations (−2)a	Undetected	Not applicable	⊕⊕ Low

Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; N/A, not applicable; RCT, randomized controlled trial; SAVR, surgical aortic valve replacement; TAVI, transaortic valve implantation.

^aStudies identified had very low statistical power to detect a difference between groups. Evidence was downgraded by two levels given very few events in intervention and control groups.

^bStudies identified had very low statistical power to detect a difference between groups.

^cPossible inconsistency in magnitude of effect.

^dOne study reported a statistically significant result, but the other one did not.

^eStudy identified had low statistical power to detect a difference between groups.