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December 1, 1991Journal of Cardiac Surgery147 citations

Allograft Aortic Valve Replacement: Long-Term Comparative Clinical Analysis of the Viable Cryopreserved and Antibiotic 4°C Stored Valves

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MOMark F. O’BrienDMDavid C. McGiffinESE. Gregory Stafford

Key Result

Cryopreserved allograft aortic valves showed superiority over 4°C stored valves, with higher 14-year survival (71% vs 57%, p=0.014) and freedom from structural deterioration (85% vs 51%, p=0.000003).

Key Points

  • To compare long-term clinical outcomes between cryopreserved and 4°C stored allograft aortic valves in patients undergoing valve replacement.
  • 534 patients underwent aortic valve replacement with either a cryopreserved valve or a 4°C stored valve.
  • Outcomes measured included mortality, thromboembolism, endocarditis, structural deterioration, and reoperation rates over 14 years.
  • Statistical analyses were performed to compare outcomes between the two valve groups.
  • 30-day mortality was 8.9% for 4°C stored valves and 2.7% for cryopreserved valves (p = 0.014).
  • 14-year patient survival was 57% for 4°C stored valves and 71% for cryopreserved valves (p = 0.014).
  • Actuarial freedom from structural deterioration was 51% for 4°C stored valves and 85% for cryopreserved valves (p = 0.000003).

Study Design

Type

Cohort (n=534)

Structured PICO

Does a cryopreserved allograft aortic valve improve long-term survival and freedom from structural deterioration compared to a 4°C stored valve in patients undergoing aortic valve replacement?

P
Population
534 patients undergoing aortic valve replacement with or without concomitant procedures using an allograft aortic valve
I
Intervention
Cryopreserved allograft aortic valve (n=410)
C
Comparator
4°C stored allograft aortic valve (n=124)
O
Outcome
Actuarial patient survival and freedom from assumed structural deterioration at 14 yearshard clinical

Cryopreserved allograft aortic valves demonstrate superior long-term performance, survival, and freedom from structural deterioration compared to 4°C stored valves.

Main Result

Absolute Event Rate: 71% vs 57%

p-value: p=0.014

Abstract

Aortic valve replacement with or without concomitant procedures was performed using an allograft aortic valve in 534 patients. From December 1969 to May 1975 (group I), a 4 degrees C stored valve was used (124 patients) and from June 1975 to July 1990 (group II), a cryopreserved valve (410 patients) was used. The 30-day mortality was 8.9% (confidence limits CL 6.2%-12.3%) for group I and 2.7% (CL 1.9%-3.8%) for group II. Actuarial patient survival including early hospital mortality at 14 years was 57% for group I and 71% for group II (p = 0.014). Actuarial freedom from thromboembolism for all patients (n = 534) was 94% at 14 years, and for patients who underwent isolated aortic valve replacement with or without coronary artery bypass graft (n = 457) was 97% at 14 years (p = 0.017). Actuarial freedom from allograft valve endocarditis at 14 years was 92% in group I and 94% in group II (p = 0.36). The actuarial freedom from moderate or severe allograft valve incompetence at 14 years was 50% (group I) and 78% (group II) (p = 0.27). Reoperation was undertaken for endocarditis, leaflet structural deterioration (SD), or technical reasons. The actuarial freedom from reoperation (all causes) at 14 years was 63% (group I) and 86% (group II) (p = 0.39). Reoperation for SD occurred in 34 patients in group I and three patients in group II. The actuarial freedom from reoperation for SD at 14 years was 67% (group I) and 95% (group II) (p = 0.001). To reflect a more accurate depiction of the prevalence of SD, patients were analyzed according to the development of "assumed structural deterioration" (at reoperation, at death with moderate or severe allograft valve incompetence and macroscopic valve deterioration on autopsy, and in the presence of moderate or severe allograft valve incompetence in patients not undergoing reoperation). The actuarial freedom from "assumed structural deterioration" at 14 years was 51% (group I) and 85% (group II) (p = 0.000003). The long-term results confirm the low incidence of thromboembolism and endocarditis regardless of the method of preservation and demonstrate the overall acceptable performance of the viable cryopreserved allograft valve and its superiority over the 4 degrees C stored valve.

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Cite This Study

O’Brien et al. (1991) conducted a cohort in Aortic valve replacement (n=534). Cryopreserved allograft aortic valve vs. 4°C stored allograft aortic valve was evaluated on Actuarial patient survival at 14 years (p=0.014). Cryopreserved allograft aortic valves showed superiority over 4°C stored valves, with higher 14-year survival (71% vs 57%, p=0.014) and freedom from structural deterioration (85% vs 51%, p=0.000003).

synapsesocial.com/papers/6a0ccbd5291fe4aa62625581https://doi.org/10.1111/jocs.1991.6.4s.534
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