Comparison of outcomes following aortic valve replacement with two different types of valve substitutes

Conditions

Aortic valve disease Circulatory System Non-rheumatic aortic valve disorders

Maximiliaan L. Notenboom, Giovanni Melina, Kevin M. Veen, Fabio De Robertis, Giuditta Coppola et al. (12 authors)

JAMA Cardiology2023-11-0837 citations

10.1001/jamacardio.2023.4090

Long-term outcomes after autograft versus homograft aortic root replacement in adults with aortic valve disease: a randomised controlled trial.

El-Hamamsy I, Eryigit Z, Stevens LM, Sarang Z, George R, Clark L, Melina G, Takkenberg JJ, Yacoub MH.

2010-08-03251 citations

10.1016/s0140-6736(10)60828-8

Interventions

Two interventions will be compared: 1. Homograft aortic root replacement with coronary reimplantation 2. Autograft aortic root replacement with coronary reimplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic aortic valve disease requiring aortic valve replacement 2. Patients with concomitant aortic root dilatation and/or ascending aortic dilatation and aortic valve dysfunction requiring surgery 3. Patients with bicuspid aortic valve disease requiring aortic valve replacement 4. Patients with aortic valve endocarditis 5. Patients who have undergone previous cardiac surgery 6. Aged less than 69 years, either sex 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Marfan syndrome 2. Reither's syndrome 3. Rheumatoid arthritis 4. Aged less than 5 years or greater than 69 years 5. Inability to consent 6. Other known disease potentially shortening life expectancy to less than 15 years 7. When completeness of follow-up is judged unlikely by the investigators

Design outcomes

Primary

Measure	Time frame
Survival at 10 years	—

Secondary

Measure	Time frame
1. Incidence of the need for reoperation 2. Quality of life (QOL): assessed using the 36-item Short Form health survey (SF-36) quality of life standardised questionnaire, which will be sent by mail with a return envelope to all patients 3. Incidence of valve-related complications: endocarditis, major bleeding, thrombosis or thromboembolism 4. Specific echocardiographic parameters: 4.1. Progression of transaortic pressure gradient 4.2. Progression in the degree of aortic regurgitation and incidence of aortic regurgitation grade 3+ and 4+ 4.3. Changes in aortic root diameter measured at the sinuses of Valsalva and incidence of aortic root dilatation greater than 45 mm 4.4. Changes in left ventricular end-diastolic and end-systolic diameters 4.5. Changes in ejection fraction 4.6. Progression of transpulmonary gradient through the homograft in the autograft group	—

Measure

Time frame

1. Incidence of the need for reoperation 2. Quality of life (QOL): assessed using the 36-item Short Form health survey (SF-36) quality of life standardised questionnaire, which will be sent by mail with a return envelope to all patients 3. Incidence of valve-related complications: endocarditis, major bleeding, thrombosis or thromboembolism 4. Specific echocardiographic parameters: 4.1. Progression of transaortic pressure gradient 4.2. Progression in the degree of aortic regurgitation and incidence of aortic regurgitation grade 3+ and 4+ 4.3. Changes in aortic root diameter measured at the sinuses of Valsalva and incidence of aortic root dilatation greater than 45 mm 4.4. Changes in left ventricular end-diastolic and end-systolic diameters 4.5. Changes in ejection fraction 4.6. Progression of transpulmonary gradient through the homograft in the autograft group

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Countries

England, United Kingdom

Outcome results

None listed