Long-Term Outcomes After Autograft Versus Homograft Aortic Root Replacement ln Adults With Aortic Valve Disease - Autograft Versus Homograft AVR

Aug 02, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Magdi Yacoub Institute
Date Published:
01/01/2010
Date Updated:
08/02/2010
Original Posted Date:
08/02/2010
References

Description:

The goal of the trial was to evaluate aortic valve replacement (AVR) by autograft (Ross procedure) compared with homograft technique among patients with severe aortic valve disease.

Hypothesis:

Autograft AVR would be more effective in improving long-term survival.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients 18-69 years of age with severe aortic valve disease

Number of enrollees: 228

Duration of follow-up: mean 10.2 years

Age: mean 38 years

Percentage female: 15%

New York Heart Association class: I 31%, II 45%, III 19%, and IV 5%

Exclusions:

  • Marfan’s syndrome
  • Rheumatoid arthritis
  • Reiter’s syndrome

Primary Endpoints:

  • Survival 10 years after surgery

Secondary Endpoints:

  • Reoperation for aortic or pulmonary valve disease

Drug/Procedures Used:

Patients undergoing AVR were randomized to aortic autograft (n = 116) versus aortic homograft (n = 112).

The autograft technique harvests the patient’s own pulmonary valve, which is then sewn into the aortic position, and a pulmonary homograft is sewn into the pulmonary position. Homograft technique prepares valves from human cadavers.

Principal Findings:

Overall, 228 patients were randomized. In the autograft group, the mean age was 38 years, 15% were women, mean body surface area was 1.9 m2, 17% were current smokers, and 17% had active or treated endocarditis. Indication for surgery: aortic stenosis in 28%, aortic regurgitation in 45%, mixed aortic stenosis/regurgitation in 27%, and thoracic aortic aneurysm in 2%. Forty-two percent of patients had previous intervention: homograft in 22%, mechanical or tissue prosthesis in 12%, aortic valve repair in 11%, or coarctation repair in 8%.

There was one perioperative death in the autograft group versus three in the homograft group (p = 0.62). Bypass time was 163 minutes versus 117 minutes (p < 0.0001), re-exploration for bleeding was 12% versus 4% (p = 0.041), sternal wound infection occurred in 4% versus 1% (p = 0.37), and median hospital stay was 9 days versus 9 days (p = 0.45), respectively.

The primary outcome, survival at 10 years, was 97% in the autograft group versus 83% in the homograft group (p = 0.006). The proportion surviving in the autograft group was similar to an age- and sex-matched United Kingdom population. Freedom from aortic valve reoperation at 13 years was 99% versus 51% (p < 0.0003), and freedom from aortic or pulmonary valve reoperation was 94% versus 51% (p < 0.0001), respectively.

Interpretation:

Among patients with severe aortic valve disease, the autograft AVR (Ross procedure) was associated with improved long-term survival compared with the homograft AVR. Survival in the autograft group was similar to an age- and sex-matched United Kingdom cohort. Procedurally, patients in the autograft group experienced longer bypass time and more reoperation for bleeding; however, the duration of the hospital stay was the same in both groups. Autograft AVR was also associated with improved freedom from reoperation on the aortic valve or aortic/pulmonary valves. Future studies are needed that compare the autograft to mechanical or xenogenic bioprosthetic valves.

References:

El-Hamamsy I, Eryigit Z, Stevens LM, et al. Long-term outcomes after autograft versus homograft aortic root replacement in adults with aortic valve disease: a randomised controlled trial. Lancet 2010;Aug 3:[Epub ahead of print].

Keywords: Heart Valve Prosthesis, Aortic Aneurysm, Thoracic, Follow-Up Studies, Heart Defects, Congenital, Allografts, Wound Infection, Pulmonary Valve, Length of Stay, Body Surface Area, Reoperation, Endocarditis, Cadaver, Autografts


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