Simple adaptations of surgical technique to critically reduce the risk of postoperative sternal complications in patients receiving bilateral internal thoracic arteries

Sakic, Adel; Chevtchik, Orest; Kilo, Juliane; Schistek, R; Mueller, Ludwig; Ulmer, Hanno; Grimm, Michael; Ruttmann, Elfriede

doi:10.1093/icvts/ivt089

Cited by 21 publications

(17 citation statements)

References 23 publications

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“…There were an additional 93 reports, reviews or notifications about harms from the use of these products from the MHRA, EMA and FDA websites. After screening and applying the eligibility criteria, eight observational studies were included [242][243][244][245][246][247][248][249] (Table 18). Three observational studies were in eye surgery, [242][243][244] three in upper GI tract surgery, [245][246][247] one in plastic/ reconstructive surgery 248 and one in vascular surgery.…”

Section: Quantity Of Observational Studies and Regulatory Body Reportsmentioning

confidence: 99%

“…Three observational studies were in eye surgery, [242][243][244] three in upper GI tract surgery, [245][246][247] one in plastic/ reconstructive surgery 248 and one in vascular surgery. 249 There were three cohort studies, 243,245,249 three comparative studies 242,244,247 and two reviews of patient records. 246,248 The following fibrin sealants were used: unspecified fibrin glue in eye surgery, [242][243][244] Tiseel, 245 Beriplast, 247 aerosolised fibrin glue 248 and platelet-enriched fibrin glue sealant.…”

Section: Quantity Of Observational Studies and Regulatory Body Reportsmentioning

confidence: 99%

“…246,248 The following fibrin sealants were used: unspecified fibrin glue in eye surgery, [242][243][244] Tiseel, 245 Beriplast, 247 aerosolised fibrin glue 248 and platelet-enriched fibrin glue sealant. 249 Comparator interventions were standard care [245][246][247][248][249] or sutures in eye surgery. [242][243][244] Sample sizes ranged from 40 243 to 529 246 participants.…”

Section: Quantity Of Observational Studies and Regulatory Body Reportsmentioning

confidence: 99%

“…Cagatay et al 242 reported that harms were assessed independently. Five studies described measurement instruments, 243,245,246,248,249 but only three studies reported timing and duration of follow-up. 243,246,249 Only Sakic et al 249 appeared to have used objective measures.…”

Section: Quality Of Observational Studiesmentioning

confidence: 99%

“…Five studies described measurement instruments, 243,245,246,248,249 but only three studies reported timing and duration of follow-up. 243,246,249 Only Sakic et al 249 appeared to have used objective measures. All eight studies, except that by Jiang et al,243 attributed the harms to the use of fibrin sealants and seven studies explained terms used to identify harms.…”

Section: Quality Of Observational Studiesmentioning

confidence: 99%

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The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms

Edwards¹,

Crawford²,

Velthoven³

et al. 2016

Health Technol Assess

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BackgroundFibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage (bleeding). However, there is uncertainty around the benefits and harms of fibrin sealant use.ObjectivesTo systematically review the evidence on the benefits and harms of fibrin sealants in non-emergency surgery in adults.Data sourcesElectronic databases [MEDLINE, EMBASE and The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and the Cochrane Central Register of Controlled Trials)] were searched from inception to May 2015. The websites of regulatory bodies (the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency and the Food and Drug Administration) were also searched to identify evidence of harms.Review methodsThis review included randomised controlled trials (RCTs) and observational studies using any type of fibrin sealant compared with standard care in non-emergency surgery in adults. The primary outcome was risk of developing seroma and haematoma. Only RCTs were used to inform clinical effectiveness and both RCTs and observational studies were used for the assessment of harms related to the use of fibrin sealant. Two reviewers independently screened all titles and abstracts to identify potentially relevant studies. Data extraction was undertaken by one reviewer and validated by a second. The quality of included studies was assessed independently by two reviewers using the Cochrane Collaboration risk-of-bias tool for RCTs and the Centre for Reviews and Dissemination guidance for adverse events for observational studies. A fixed-effects model was used for meta-analysis.ResultsWe included 186 RCTs and eight observational studies across 14 surgical specialties and five reports from the regulatory bodies. Most RCTs were judged to be at an unclear risk of bias. Adverse events were inappropriately reported in observational studies. Meta-analysis across non-emergency surgical specialties did not show a statistically significant difference in the risk of seroma for fibrin sealants versus standard care in 32 RCTs analysed [n = 3472, odds ratio (OR) 0.84, 95% confidence interval (CI) 0.68 to 1.04;p = 0.13;I2 = 12.7%], but a statistically significant benefit was found on haematoma development in 24 RCTs (n = 2403, OR 0.62, 95% CI 0.44 to 0.86;p = 0.01;I2 = 0%). Adverse events related to fibrin sealant use were reported in 10 RCTs and eight observational studies across surgical specialties, and 22 RCTs explicitly stated that there were no adverse events. One RCT reported a single death but no other study reported mortality or any serious adverse events. Five regulatory body reports noted death from air emboli associated with fibrin sprays.LimitationsIt was not possible to provide a detailed evaluation of individual RCTs in their specific contexts because of the limited resources that were available for this research. In addition, the number of RCTs that were identified made it impractical to conduct independent data extraction by two reviewers in the time available.ConclusionsThe effectiveness of fibrin sealants does not appear to vary according to surgical procedures with regard to reducing the risk of seroma or haematoma. Surgeons should note the potential risk of gas embolism if spray application of fibrin sealants is used and not to exceed the recommended pressure and spraying distance. Future research should be carried out in surgery specialties for which only limited data were found, including neurological, gynaecological, oral and maxillofacial, urology, colorectal and orthopaedics surgery (for any outcome); breast surgery and upper gastrointestinal (development of haematoma); and cardiothoracic heart or lung surgery (reoperation rates). In addition, studies need to use adequate sample sizes, to blind participants and outcome assessors, and to follow reporting guidelines.Study registrationThis study is registered as PROSPERO CRD42015020710.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Quantity Of Observational Studies and Regulatory Body Reportsmentioning

confidence: 99%

Section: Quantity Of Observational Studies and Regulatory Body Reportsmentioning

confidence: 99%

Section: Quantity Of Observational Studies and Regulatory Body Reportsmentioning

confidence: 99%

Section: Quality Of Observational Studiesmentioning

confidence: 99%

Section: Quality Of Observational Studiesmentioning

confidence: 99%

See 3 more Smart Citations

The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms

Edwards¹,

Crawford²,

Velthoven³

et al. 2016

Health Technol Assess

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Pure Bilateral Internal Thoracic Artery Grafting in Diabetic Patients With Triple-Vessel Disease

Jeong

Sung

Lee

et al. 2015

The Annals of Thoracic Surgery

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The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting

Aldea

Bakaeen²,

Pal

et al. 2016

The Annals of Thoracic Surgery

307

220

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Internal thoracic arteries (ITAs) should be used to bypass the left anterior descending (LAD) artery when bypass of the LAD is indicated (class of recommendation [COR] I, level of evidence [LOE] B). As an adjunct to left internal thoracic artery (LITA), a second arterial graft (right ITA or radial artery [RA]) should be considered in appropriate patients (COR IIa, LOE B). Use of bilateral ITAs (BITAs) should be considered in patients who do not have an excessive risk of sternal complications (COR IIa, LOE B). To reduce the risk of sternal infection with BITA, skeletonized grafts should be considered (COR IIa, LOE B), smoking cessation is recommended (COR I, LOE C), glycemic control should be considered (COR IIa, LOE B), and enhanced sternal stabilization may be considered (COR IIb, LOE C). As an adjunct to LITA to LAD (or in patients with inadequate LITA grafts), use of a RA graft is reasonable when grafting coronary targets with severe stenoses (COR IIa, LOE: B). When RA grafts are used, it is reasonable to use pharmacologic agents to reduce acute intraoperative and perioperative spasm (COR IIa, LOE C). The right gastroepiploic artery may be considered in patients with poor conduit options or as an adjunct to more complete arterial revascularization (COR IIb, LOE B). Use of arterial grafts (specific targets, number, and type) should be a part of the discussion of the heart team in determining the optimal approach for each patient (COR I, LOE C).

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Simple adaptations of surgical technique to critically reduce the risk of postoperative sternal complications in patients receiving bilateral internal thoracic arteries

Abstract: Adjusted for common risk factors, skeletonization of BITA grafts together with augmented sternal wires is effective in preventing sternal complications. The use of PRF sealant, however, increased the risk for superficial wound complications.

Cited by 21 publications

References 23 publications

The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms

The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms

Pure Bilateral Internal Thoracic Artery Grafting in Diabetic Patients With Triple-Vessel Disease

The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting

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