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Esternotomía parcial versus total para el reemplazo de la válvula aórtica

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Appendices

Appendix 1. Search strategies

CENTRAL

#1 MeSH descriptor: [Aortic Valve] this term only

#2 (aortic valve* near/3 (operation* or replace* or surgery)):ti,ab,kw

#3 #1 or #2

#4 MeSH descriptor: [Minimally Invasive Surgical Procedures] this term only

#5 MeSH descriptor: [Robotics] this term only

#6 MeSH descriptor: [Thoracoscopy] explode all trees

#7 MeSH descriptor: [Sternotomy] this term only

#8 minim* invasiv*:ti,ab,kw

#9 ((surgical or surgery or surgeries or replacement* or operation*) near/3 minim*):ti,ab,kw

#10 ((surgery or surgeries or surgical) near/3 (keyhole or percutaneous or robot‐assisted)):ti,ab,kw

#11 thoracoscop*:ti,ab,kw

#12 pleuroscop*:ti,ab,kw

#13 ("hemi‐sternotomy" or "mini‐sternotomy"):ti,ab,kw

#14 #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13

#15 #3 and #14

MEDLINE Ovid

1. Aortic Valve/

2. (aortic valve* adj3 (operation* or replace* or surgery)).tw.

3. 1 or 2

4. Surgical Procedures, Minimally Invasive/

5. Robotics/

6. Thoracoscopy/

7. Sternotomy/

8. minim* invasiv*.tw.

9. ((surgical or surgery or surgeries or replacement* or operation*) adj3 minim*).tw.

10. ((surgery or surgeries or surgical) adj3 (keyhole or percutaneous or robot‐assisted)).tw.

11. thoracoscop*.tw.

12. pleuroscop*.tw.

13. ("hemi‐sternotomy" or "mini‐sternotomy").tw.

14. or/4‐13

15. 3 and 14

16. exp animals/ not humans.sh.

17. 15 not 16

18. randomized controlled trial.pt.

19. controlled clinical trial.pt.

20. randomized.ab.

21. placebo.ab.

22. drug therapy.fs.

23. randomly.ab.

24. trial.ab.

25. groups.ab.

26. 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25

27. exp animals/ not humans.sh.

28. 26 not 27

29. 17 and 28

Embase Ovid

1. Aorta Valve/

2. (aortic valve* adj3 (operation* or replace* or surgery)).tw.

3. 1 or 2

4. Minimally Invasive Surgery/

5. Robotics/

6. Thoracoscopy/

7. Sternotomy/

8. minim* invasiv*.tw.

9. ((surgical or surgery or surgeries or replacement* or operation*) adj3 minim*).tw.

10. ((surgery or surgeries or surgical) adj3 (keyhole or percutaneous or robot‐assisted)).tw.

11. thoracoscop*.tw.

12. pleuroscop*.tw.

13. ("hemi‐sternotomy" or "mini‐sternotomy").tw.

14. or/4‐13

15. 3 and 14

16. exp animals/ not humans.sh.

17. 15 not 16

18. random$.tw.

19. factorial$.tw.

20. crossover$.tw.

21. cross over$.tw.

22. cross‐over$.tw.

23. placebo$.tw.

24. (doubl$ adj blind$).tw.

25. (singl$ adj blind$).tw.

26. assign$.tw.

27. allocat$.tw.

28. volunteer$.tw.

29. crossover procedure/

30. double blind procedure/

31. randomized controlled trial/

32. single blind procedure/

33. 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32

34. (animal/ or nonhuman/) not human/

35. 33 not 34

36. 17 and 35

Clinicaltrials.gov

"aortic valve" AND ("minimally invasive" OR "hemi‐sternotomy" OR "mini‐sternotomy")

WHO International Clinical Trials Registry Platform

"aortic valve" AND ("minimally invasive" OR "hemi‐sternotomy" OR "mini‐sternotomy")

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 1 Mortality.
Figures and Tables -
Analysis 1.1

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 1 Mortality.

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 2 Cardiopulmonary bypass time (minutes).
Figures and Tables -
Analysis 1.2

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 2 Cardiopulmonary bypass time (minutes).

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 3 Aortic cross‐clamp time (minutes).
Figures and Tables -
Analysis 1.3

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 3 Aortic cross‐clamp time (minutes).

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 4 Length of hospital stay (days).
Figures and Tables -
Analysis 1.4

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 4 Length of hospital stay (days).

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 5 Postoperative blood loss (mL).
Figures and Tables -
Analysis 1.5

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 5 Postoperative blood loss (mL).

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 6 Deep sternal wound infection.
Figures and Tables -
Analysis 1.6

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 6 Deep sternal wound infection.

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 7 Pain scores.
Figures and Tables -
Analysis 1.7

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 7 Pain scores.

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 8 Quality of life.
Figures and Tables -
Analysis 1.8

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 8 Quality of life.

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 9 Intensive care unit length of stay (days).
Figures and Tables -
Analysis 1.9

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 9 Intensive care unit length of stay (days).

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 10 Postoperative pulmonary function tests (% FEV1).
Figures and Tables -
Analysis 1.10

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 10 Postoperative pulmonary function tests (% FEV1).

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 11 Re‐exploration.
Figures and Tables -
Analysis 1.11

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 11 Re‐exploration.

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 12 Postoperative atrial fibrillation.
Figures and Tables -
Analysis 1.12

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 12 Postoperative atrial fibrillation.

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 13 Postoperative ventilation time (hours).
Figures and Tables -
Analysis 1.13

Comparison 1 Limited versus full sternotomy aortic valve replacement, Outcome 13 Postoperative ventilation time (hours).

Summary of findings for the main comparison. Limited upper hemi‐sternotomy versus full median sternotomy for aortic valve replacement

Limited upper hemi‐sternotomy versus full median sternotomy for aortic valve replacement

Patient or population: participants requiring aortic valve replacement
Setting: cardiac surgical centres
Intervention: limited sternotomy
Comparison: full sternotomy

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with Full Sternotomy

Risk with Limited Sternotomy

Mortality

Follow‐up: in‐patient stay

Study population

RR 1.01
(0.36 to 2.82)

511
(7 RCTs)

⊕⊕⊕⊝
Moderate1

23 per 1000

24 per 1000
(8 to 66)

Cardiopulmonary bypass time

The mean cardiopulmonary bypass time ranged from 71 to 107 minutes

The mean cardiopulmonary bypass time in the intervention group was 3.02 minutes more (4.1 fewer to 10.14 more)

311
(5 RCTs)

⊕⊕⊝⊝
Low2,3

Cardiopulmonary bypass times tend to have high variability between surgeons according to surgical technique. Differences of up to 15 minutes are unlikely to have clinical significance.

Aortic cross‐clamp time

The mean aortic cross‐clamp time ranged from 46 to 72 minutes

The mean aortic cross‐clamp time in the intervention group was 0.95 minutes more (3.45 fewer to 5.35 more)

391
(6 RCTs)

⊕⊕⊝⊝
Low3,4

Ischaemic times tend to have high variability between surgeons according to surgical technique. Differences of up to 10 minutes are unlikely to have clinical significance.

Length of hospital stay

Follow‐up: in‐patient stay

The mean length of hospital stay ranged from 6.0 to 9.3 days

The mean length of hospital stay in the intervention group was 1.31 days lower (2.63 lower to 0.01 higher)

297
(5 RCTs)

⊕⊝⊝⊝
Very low5,6,7

Expediency of discharge is a quality marker in some healthcare systems, but not universally.

Postoperative blood loss

Follow‐up: until removal of operative drains

The mean postoperative blood loss ranged from 280 mL to 590 mL

The mean postoperative blood loss in the intervention group was 158 mL lower (303 lower to 12 lower)

297
(5 RCTs)

⊕⊕⊕⊝
Moderate8

Deep sternal wound infection

Follow‐up: not specified

Study population

RR 0.71
(0.22 to 2.30)

511
(7 RCTs)

⊕⊕⊕⊝
Moderate1

23 per 1000

17 per 1000
(5 to 54)

Pain scores

Follow‐up: 12 hours

The mean pain scores ranged from 1.2 to 16 standard deviations

The mean pain scores in the intervention group was 0.3 standard deviations fewer (0.85 fewer to 0.2 more)

197
(3 RCTs)

⊕⊝⊝⊝
Very low7,8,9

The assessment of pain within and across studies was insufficiently standardised to make strong conclusions about effect on pain

Intensive care unit length of stay

The mean intensive care unit stay was 1.4 to 2.1 days

The mean intensive care unit stay in the intervention group was 0.57 days lower (0.93 lower to 0.2 lower)

297
(5 RCTs)

⊕⊕⊝⊝
Low7,8

Postoperative pulmonary function tests

Follow‐up: 5 to 7 days

The mean pulmonary function tests ranged from 53% to 82% predicted FEV1

The mean pulmonary function tests in the intervention group was 1.98% predicted FEV1 higher (0.62 higher to 3.33 higher)

257
(4 RCTs)

⊕⊕⊝⊝
Low7,10

Re‐exploration

Follow‐up: in‐patient stay

Study population

RR 1.01
(0.48 to 2.13)

511
(7 RCTs)

⊕⊕⊕⊝
Moderate1

47 per 1000

47 per 1000
(22 to 99)

Postoperative atrial fibrillation

Follow‐up: in‐patient stay

Study population

RR 0.60
(0.07 to 4.89)

240
(3 RCTs)

⊕⊕⊝⊝
Low8,11

175 per 1000

105 per 1000
(12 to 856)

Postoperative ventilation time

The mean postoperative ventilation time ranged from 5.3 to 13.2 hours

The mean postoperative ventilation time in the intervention group was 1.12 hours lower (3.43 lower to 1.19 higher)

297
(6 RCTs)

⊕⊝⊝⊝
Very low7,8,11

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; FEV1: forced expiratory volume in 1 second; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1 Downgraded for imprecision: sample size did not meet Optimal Information Size criteria and 95% confidence intervals overlapped no effect. Optimal Information Size estimated at 4600 (to determine 1% difference using α 0.05, β 0.20). Studies all had fewer than 100 participants.

2 Downgraded for imprecision: sample size did not meet Optimal Information Size criteria and 95% confidence intervals overlapped no effect. Optimal Information Size estimated at 120 (to determine 15‐minute difference using α 0.05, β 0.80). Studies all had fewer than 100 participants.

3 Downgraded for inconsistency: use of rapid deployment valves in one study and other variations in surgical technique lead to high heterogeneity.

4 Downgraded for imprecision: sample size did not meet Optimal Information Size criteria and 95% confidence intervals overlapped no effect. Optimal Information Size estimated at 100 (to determine 10‐minute difference in mortality using α 0.05, β 0.80). Studies all had fewer than 100 participants.

5 Downgraded for imprecision: sample size did not meet Optimal Information Size criteria and 95% confidence intervals overlapped no effect. Optimal Information Size estimated at 140 (to determine 1‐day difference using α 0.05, β 0.80). Studies all had fewer than 100 participants.

6 Downgraded for indirectness: length of stay is a surrogate marker of quality and national variations exist in discharge criteria.

7 Downgraded for high risk of bias: outcome measure sensitive to lack of blinding in study.

8 Downgraded for inconsistency: variations in surgical or anaesthetic technique lead to high heterogeneity.

9 Downgraded for indirectness: different measures of pain used across studies.

10 Downgraded for inconsistency: different timing of postsurgical lung function tests across studies lead to high heterogeneity.

11 Downgraded for imprecision: wide 95% confidence intervals overlapping no effect.

Figures and Tables -
Summary of findings for the main comparison. Limited upper hemi‐sternotomy versus full median sternotomy for aortic valve replacement
Comparison 1. Limited versus full sternotomy aortic valve replacement

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

7

511

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.36, 2.82]

2 Cardiopulmonary bypass time (minutes) Show forest plot

5

311

Mean Difference (IV, Random, 95% CI)

3.02 [‐4.10, 10.14]

3 Aortic cross‐clamp time (minutes) Show forest plot

6

391

Mean Difference (IV, Random, 95% CI)

0.95 [‐3.45, 5.35]

4 Length of hospital stay (days) Show forest plot

5

297

Mean Difference (IV, Random, 95% CI)

‐1.31 [‐2.63, 0.01]

5 Postoperative blood loss (mL) Show forest plot

5

297

Mean Difference (IV, Random, 95% CI)

‐158.00 [‐303.24, ‐12.76]

6 Deep sternal wound infection Show forest plot

7

511

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.22, 2.30]

7 Pain scores Show forest plot

3

197

Std. Mean Difference (IV, Random, 95% CI)

‐0.33 [‐0.85, 0.20]

8 Quality of life Show forest plot

1

100

Mean Difference (IV, Fixed, 95% CI)

0.0 [‐0.04, 0.04]

9 Intensive care unit length of stay (days) Show forest plot

5

297

Mean Difference (IV, Random, 95% CI)

‐0.57 [‐0.93, ‐0.20]

10 Postoperative pulmonary function tests (% FEV1) Show forest plot

4

257

Mean Difference (IV, Fixed, 95% CI)

1.98 [0.62, 3.33]

11 Re‐exploration Show forest plot

7

511

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.48, 2.13]

12 Postoperative atrial fibrillation Show forest plot

3

240

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.07, 4.89]

13 Postoperative ventilation time (hours) Show forest plot

5

297

Mean Difference (IV, Random, 95% CI)

‐1.12 [‐3.43, 1.19]

Figures and Tables -
Comparison 1. Limited versus full sternotomy aortic valve replacement