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Meta-Analysis
. 2017 Apr 10;4(4):CD011793.
doi: 10.1002/14651858.CD011793.pub2.

Limited versus full sternotomy for aortic valve replacement

Bilal H Kirmani  1 , Sion G Jones  1 , S C Malaisrie  2 , Darryl A Chung  1 , Richard Jnn Williams  1
Affiliations
Meta-Analysis

Limited versus full sternotomy for aortic valve replacement

Bilal H Kirmani et al. Cochrane Database Syst Rev. .

Update in

  • Limited versus full sternotomy for aortic valve replacement.
    Kirmani BH, Jones SG, Muir A, Malaisrie SC, Chung DA, Williams RJ, Akowuah E. Kirmani BH, et al. Cochrane Database Syst Rev. 2023 Dec 6;12(12):CD011793. doi: 10.1002/14651858.CD011793.pub3. Cochrane Database Syst Rev. 2023. PMID: 38054555 Free PMC article.

Abstract

Background: Aortic valve disease is a common condition that is easily treatable with cardiac surgery. This is conventionally performed by opening the sternum longitudinally down the centre ("median sternotomy") and replacing the valve under cardiopulmonary bypass. Median sternotomy is generally well tolerated, but as less invasive options have become available, the efficacy of limited incisions has been called into question. In particular, the effects of reducing the visibility and surgical access has raised safety concerns with regards to the placement of cannulae, venting of the heart, epicardial wire placement, and de-airing of the heart at the end of the procedure. These difficulties may increase operating times, affecting outcome. The benefits of smaller incisions are thought to include decreased pain; improved respiratory mechanics; reductions in wound infections, bleeding, and need for transfusion; shorter intensive care stay; better cosmesis; and a quicker return to normal activity.

Objectives: To assess the effects of minimally invasive aortic valve replacement via a limited sternotomy versus conventional aortic valve replacement via median sternotomy in people with aortic valve disease requiring surgical replacement.

Search methods: We performed searches of CENTRAL, MEDLINE, Embase, clinical trials registries, and manufacturers' websites from inception to July 2016, with no language limitations. We reviewed references of identified papers to identify any further studies of relevance.

Selection criteria: Randomised controlled trials comparing aortic valve replacement via a median sternotomy versus aortic valve replacement via a limited sternotomy. We excluded trials that performed other minimally invasive incisions such as mini-thoracotomies, port access, trans-apical, trans-femoral or robotic procedures. Although some well-conducted prospective and retrospective case-control and cohort studies exist, these were not included in this review.

Data collection and analysis: Two review authors independently assessed trial papers to extract data, assess quality, and identify risk of bias. A third review author provided arbitration where required. The quality of evidence was determined using the GRADE methodology and results of patient-relevant outcomes were summarised in a 'Summary of findings' table.

Main results: The review included seven trials with 511 participants. These included adults from centres in Austria, Spain, Italy, Germany, France, and Egypt. We performed 12 comparisons investigating the effects of minimally invasive limited upper hemi-sternotomy on aortic valve replacement as compared to surgery performed via full median sternotomy.There was no evidence of any effect of upper hemi-sternotomy on mortality versus full median sternotomy (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.36 to 2.82; participants = 511; studies = 7; moderate quality). There was no evidence of an increase in cardiopulmonary bypass time with aortic valve replacement performed via an upper hemi-sternotomy (mean difference (MD) 3.02 minutes, 95% CI -4.10 to 10.14; participants = 311; studies = 5; low quality). There was no evidence of an increase in aortic cross-clamp time (MD 0.95 minutes, 95% CI -3.45 to 5.35; participants = 391; studies = 6; low quality). None of the included studies reported major adverse cardiac and cerebrovascular events as a composite end point.There was no evidence of an effect on length of hospital stay through limited hemi-sternotomy (MD -1.31 days, 95% CI -2.63 to 0.01; participants = 297; studies = 5; I2 = 89%; very low quality). Postoperative blood loss was lower in the upper hemi-sternotomy group (MD -158.00 mL, 95% CI -303.24 to -12.76; participants = 297; studies = 5; moderate quality). The evidence did not support a reduction in deep sternal wound infections (RR 0.71, 95% CI 0.22 to 2.30; participants = 511; studies = 7; moderate quality) or re-exploration (RR 1.01, 95% CI 0.48 to 2.13; participants = 511; studies = 7; moderate quality). There was no change in pain scores by upper hemi-sternotomy (standardised mean difference (SMD) -0.33, 95% CI -0.85 to 0.20; participants = 197; studies = 3; I2 = 70%; very low quality), but there was a small increase in postoperative pulmonary function tests with minimally invasive limited sternotomy (MD 1.98 % predicted FEV1, 95% CI 0.62 to 3.33; participants = 257; studies = 4; I2 = 28%; low quality). There was a small reduction in length of intensive care unit stays as a result of the minimally invasive upper hemi-sternotomy (MD -0.57 days, 95% CI -0.93 to -0.20; participants = 297; studies = 5; low quality). Postoperative atrial fibrillation was not reduced with minimally invasive aortic valve replacement through limited compared to full sternotomy (RR 0.60, 95% CI 0.07 to 4.89; participants = 240; studies = 3; moderate quality), neither were postoperative ventilation times (MD -1.12 hours, 95% CI -3.43 to 1.19; participants = 297; studies = 5; low quality). None of the included studies reported cost analyses.

Authors' conclusions: The evidence in this review was assessed as generally low to moderate quality. The study sample sizes were small and underpowered to demonstrate differences in outcomes with low event rates. Clinical heterogeneity both between and within studies is a relatively fixed feature of surgical trials, and this also contributed to the need for caution in interpreting results.Considering these limitations, there was uncertainty of the effect on mortality or extracorporeal support times with upper hemi-sternotomy for aortic valve replacement compared to full median sternotomy. The evidence to support a reduction in total hospital length of stay or intensive care stay was low in quality. There was also uncertainty of any difference in the rates of other, secondary outcome measures or adverse events with minimally invasive limited sternotomy approaches to aortic valve replacement.There appears to be uncertainty between minimally invasive aortic valve replacement via upper hemi-sternotomy and conventional aortic valve replacement via a full median sternotomy. Before widespread adoption of the minimally invasive approach can be recommended, there is a need for a well-designed and adequately powered prospective randomised controlled trial. Such a study would benefit from performing a robust cost analysis. Growing patient preference for minimally invasive techniques merits thorough quality-of-life analyses to be included as end points, as well as quantitative measures of physiological reserve.

PubMed Disclaimer

Conflict of interest statement

BHK: none known.

SGJ: none known.

SCM consults for Edwards Lifesciences, a manufacturer of equipment for minimal incision surgery. He is on the Advisory Board for Minimally Invasive Surgery, as well as being a member of the Speaker's Bureau. He is also an investigator on the PARTNER II trial, a prospective, multi‐centre, open‐label trial of people undergoing aortic valve surgery for severe aortic stenosis that includes transcatheter valve implantation strategies. As a result, he was not involved in screening of titles or abstracts, did not assess full‐texts or contribute to data‐abstraction (except for arbitration) and did not engage in assessing risk of bias or quality of evidence assessments.

DC: has a practice that includes minimally invasive aortic valve replacement.

RJNNW: has a practice that includes minimally invasive aortic valve replacement.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 1 Mortality.
1.2
1.2. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 2 Cardiopulmonary bypass time (minutes).
1.3
1.3. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 3 Aortic cross‐clamp time (minutes).
1.4
1.4. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 4 Length of hospital stay (days).
1.5
1.5. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 5 Postoperative blood loss (mL).
1.6
1.6. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 6 Deep sternal wound infection.
1.7
1.7. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 7 Pain scores.
1.8
1.8. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 8 Quality of life.
1.9
1.9. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 9 Intensive care unit length of stay (days).
1.10
1.10. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 10 Postoperative pulmonary function tests (% FEV1).
1.11
1.11. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 11 Re‐exploration.
1.12
1.12. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 12 Postoperative atrial fibrillation.
1.13
1.13. Analysis
Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 13 Postoperative ventilation time (hours).
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References

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References to studies awaiting assessment

ISRCTN29567910 (MAVRIC) {published data only}
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References to ongoing studies

NCT02272621 {published data only}
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