what surgery is used to seal a for collasped lung

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• Published: 08 Oct 2012

Use of a sealant to preclude prolonged air leaks after lung resection: a prospective randomized study

Journal of Cardiothoracic Surgery volume 7, Article number:106 (2012) Cite this article

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Abstruse

Background

Pulmonary air leaks are mutual complications of lung resection and result in prolonged hospital stays and increased costs. The purpose of this report was to investigate whether, compared with standard care, the use of a synthetic polyethylene glycol matrix (CoSeal®) could reduce air leaks detected by means of a digital chest bleed system (DigiVent™), in patients undergoing lung resection (sutures and/or staples alone).

Methods

Patients who intraoperatively showed moderate or severe air leaks (evaluated by water submersion tests) were intraoperatively randomized to receive simply sutures/staples (command grouping) or sutures/staples plus CoSeal® (sealant group). Differences amongst the groups in terms of air leaks, prolonged air leaks, fourth dimension to chest tube removal, length of hospital stay and related costs were assessed.

Results

In total, 216 lung resection patients completed the study. Nineteen patients (18.1%) in the control grouping and 12 (ten.8%) patients in the sealant grouping experienced postoperative air leaks, while a prolonged air leak was recorded in 11.4% (north = 12) of patients in the control group and two.7% (northward = three) of patients in the sealant group. The difference in the incidence of air leaks and prolonged air leaks between the two groups was statistically pregnant (p = 0.0002 and p = 0.0013). The mean length of hospital stay was significantly shorter in the sealant group (4 days) than the control group (8 days) (p = 0.0001). Nosotros as well observed lower costs in the sealant group than the control group.

Determination

The use of CoSeal® may decrease the occurrence and severity of postoperative air leaks after lung resection and is associated with shorter hospital stay.

Trial registration

Non registered. The trial was approved by the Institutional Review Board of the IRCCS-CROB Basilicata Regional Cancer Institute, Rionero in Vulture, Italy.

Peer Review reports

Background

Pulmonary air leaks are a common complication in patients undergoing constituent lung resection and result in prolonged hospital stays and greater healthcare costs[1]. 'Prolonged' air leaks (PAL) take previously been defined as leakages lasting beyond the 7^thursday postoperative twenty-four hours[two]. However, with the aim of safely discharging patients on the 4^thursday–5^th postoperative day, it has been suggested that the definition of PAL should be modified to include any leak lasting longer than v days[three].

Major risk factors for developing pulmonary air leaks include emphysema, diabetes mellitus, incomplete interlobar fissures, the presence of pleural adhesions, and depression levels of serum albumin and cholinesterase; other factors that tin cause pulmonary air leaks include the creation of new fissures, dissection of adhesions, manipulation of the lung, and suturing with staplers[4].

Despite the employ of techniques developed to minimize the occurrence of air leaks, such as pleural tenting afterwards upper lobe resection, phrenic nerve crush, pneumoperitoneum and fissureless surgery[5–viii], PALs still have an incidence ranging from xv to 18% after routine pulmonary resection and are oftentimes accompanied by a series of events, that may have a negative bear upon on the patient's recovery, prolong the length of stay and enhance hospital costs. Complications such as these underlie the high level of involvement shown in the international literature for a phenomenon that could be considered every bit widespread as it is ambiguous.

The preferred method to reduce air leaks is to foreclose them from occurring; therefore, care should be taken to perform an accurate dissection of the structures forth well-divers anatomical planes betwixt the segments and lobes of the lung. Nevertheless, attention has focused on modifying chest drains to allow authentic measurement of transpleural air flows and towards the apply of products that aim to prevent parenchymal air leaks.

The use of traditional chest drains to find air leaks is substantially analogical, equally it is based on the principle of identifying air bubbling on the surface of a water valve and thus is largely dependent on the observers' impressions. Recently, digital pleural drainage units, the epitome of which is the DigiVent™ (Millicore A.B., Sweden), have immune measurement and direct interpretation of transpleural air flows (in ml/min) and pleural pressures (p_i, inspiratory pressure and p_e, expiratory force per unit area, in cm H₂O), measured extemporaneously and according to a cumulative reading taken over 1, iii and 6 h. Further details of the characteristics of the DigiVent™ system have been described previously[nine–13].

The treatment of air leaks ranges from direct suture with thread or staples, to cauterization or light amplification by stimulated emission of radiation vaporization; or from the simple use of Heimlich valves until the leak resolves, to the use of biological or synthetic glues and sealants. A number of different types of surgical sealant have been developed to forbid or reduce postoperative alveolar air leaks, including: fibrin sealants, collagen fleeces, and glutaraldehyde- or polyethylene glycol (PEG)-based synthetic glues. Surgical sealants are specially useful in cases where PAL cannot be controlled by sutures or staples alone.

Of the available surgical sealants, much of the literature has focused on CoSeal® (Baxter Healthcare, Deerfield, IL, U.s.), a biocompatible PEG polymer. CoSeal® is composed of ii synthetic PEGs: a dilute hydrogen chloride solution and a sodium phosphate/carbonate solution. At the fourth dimension of assistants, the solutions combine to form a hydrogel, which cantankerous-links with proteins, causing immediate adherence to the tissues. The sealant is completely absorbed by the body within xxx days of application[xiv].

The aim of this prospective, randomized written report was to evaluate the role of a synthetic PEG matrix, CoSeal®, in reducing parenchymal air leaks detected by a digital chest drainage system, DigiVent™, compared with standard treatment (suture and/or staples).

Methods

Patients

The study was conducted between March 2008 and December 2011. A total of 1080 sequent patients who had undergone lung resections were enrolled. The trial was approved by the Institutional Review Board of the IRCCS-CROB Basilicata Regional Cancer Institute, Rionero in Vulture, Italy, and was performed in accordance with best practise in Italy. All patients provided written informed consent prior to enrollment.

The inclusion criteria were: males or females ≥xviii years of age undergoing lung resection (bilobectomy or lobectomy, anatomical and atypical segment resection) or pleurectomy/decortication. Exclusion criteria were: immunodeficiency, patients undergoing bronchoplastic procedures, and known hypersensitivity to whatever component of the investigational products. Although CoSeal is contraindicated in pleural decortications, we did non exclude these patients (n = 3) because in our long experience we have not experienced any problems with increased air leaks or inflammatory complications.

Surgical procedures

Resectability was evaluated by computed tomography (CT) scan, bronchoscopy and mediastinoscopy, if indicated. Operability was assessed past arterial claret gas analysis, pulmonary function tests, electrocardiogram and echocardiography.

All pulmonary resections were performed at a single institution by one of four attending thoracic surgeons through an anterior-lateral muscle-sparing thoracotomy in the iv^thursday–5^th intercostal infinite, or a video-assisted thoracoscopy. Mechanical staplers (EndoGIA 30 or 45–4.8 mm) were used to develop incomplete fissures and close the bronchus (transverse anastomosis [TA] 30 mm). A complete hilar-mediastinal lymphadenectomy was performed in all patients.

Afterwards re-aggrandizement of the operated lung (peak pressure of 25 cm H₂O), air leaks were detected by immersing the lung in saline and rated every bit: 0 = no evidence of air leak; 1 = moderate air leaks, characterized by not-coalescent single bubbling; and two = astringent air leaks, with coalescent bubbles.

Patients with moderate or astringent air leaks were randomized to one of two groups: control grouping, in which intraoperative air leaks were treated past direct manual or stapler suture; or sealant group, in which air leaks were treated with sutures/staples plus CoSeal®. Following the submersion test for air leaks, the surface to exist treated was dried to allow proper adherence of the sealant. The sealant was administered on the suture lines or lung surfaces identified as the source of leakage and a 2d test for air tightness was performed; if there was still an air leak, the sealant was reapplied and a third test was subsequently conducted. In patients in the control group, the persistence or absence of an air leak was registered without further intervention. This study design was chosen to best reflect routine surgical practice, where lung surgery patients who receive standard care (sutures/staples and no sealant application) are airtight upwardly without further intervention, even if an intraoperative air leak persists. Similarly, in the sealant grouping, the possibility for a second application of the product reflects the standard practice of sealant use by surgeons.

Chest tube management

Two 28 French multi-fenestrated breast tubes were positioned before the closure of the thoracotomy after lobectomies, bilobectomies, and decortications: one anteriorly near the apex and one in a postero-basal position. Patients who underwent wedge resection had but one drain inserted, with the exception of cases of astringent bullous emphysema.

Chest drains were examined twice daily (once in the morning and once in the afternoon) and withdrawn if the volume of tuckered fluid was ≤250 ml in 24 h; provided at that place was no frank blood, the mean transpleural air period recorded by the digital system was <20 ml/min, instantaneous air flow spikes were ≤200 ml/min and radiological features excluded a pneumothorax >20% of the operated hemithorax.

Randomization

Patients in which a moderate or severe air leak was observed before thoracotomy closure were randomized (1:1). Randomization was performed by a shuffled, sealed envelope technique and envelopes containing the group allocation were opened in the operating room.

Statistical analysis

The post-obit postoperative variables were considered: incidence of postoperative air leaks, defined every bit mean air flow ≥20 ml/min recorded by the DigiVent™ software, prove of prolonged air leaks (divers every bit an air leak lasting ≥five days) and length of hospital stay.

Results are given equally hateful values. For chiselled variables, the statistical significance of differences between the control group and sealant grouping were determined using the Chi-square examination. Numerical variables were compared using an unpaired Students t test. A p-value of <0.05 was considered meaning.

Results

Written report population

Of the 1080 patients enrolled in the study, 222 patients were randomized (1:1) to command (n = 111) or sealant (n = 111) (Figure1). A total of 6 patients in the control group were excluded from the assay due to incomplete postoperative information. Therefore, a total of 105 patients were included in the analysis for the control group (n = 71 males and n = 34 females) and a total of 111 patients (n = 65 males and n = 46 females) for the sealant group.

Figure 1

Patient flow through the report.

Total size prototype

The two treatment groups were comparable in terms of gender distribution, mean age, 'pack years' (number of years as a smoker, multiplied past the average number of cigarettes smoked per day), hateful preoperative forced expiratory volume in one second (FEV_i), mean predicted postoperative FEV₁ (ppoFEV_i), pathology and surgical procedures, equally shown in Tables1,2 and3.

Tabular array 1 Patient characteristics

Full size table

Table two Patient characteristics: lung diseases

Full size table

Table iii Surgical procedures and approaches

Full size table

Efficacy

The incidence of postoperative air leaks, divers as hateful transpleural air flow ≥xx ml/min in 24 h with instantaneous air period peaks ≥200 ml/min, as detected by a digital chest drain system, was significantly lower in the sealant group than the control group (sealant group: 12/111 patients, 10.8%; control grouping: 19/105 patients, 18.1%; p = 0.0002; Table4).

Tabular array 4 Postoperative outcomes

Full size table

Prolonged air leaks, divers as a leakage lasting beyond the five^th postoperative day, were recorded in 2.seven% (three/111) of patients in the sealant group and in 11.4% (12/105) of patients in the control group. The lower incidence of prolonged air leaks in the sealant grouping compared with the control group was statistically significant (p = 0.0013; Table4).

The mean length of infirmary stay was significantly shorter in the sealant group than the control group (4 versus 8 days; p < 0.0001) (Table4). The mean number of breast X-rays performed during the hospital stay was iii per patient.

Discussion

Alveolar air leak is by and large considered to be the most important complication following lung resection and is the leading cause of postoperative pulmonary morbidity, prolonged length of infirmary stay and increased hospital costs.

Intraoperative air leaks post-obit pulmonary resections are reported in 48–seventy% of cases[15].

There are several studies that have observed that various surgical sealants are condom and effective treatments for intraoperative air leaks following lung resection[sixteen–21]. Iii prospective, randomized studies accept recently investigated the role of CoSeal® in preventing, or reducing the incidence of alveolar air leaks afterward lung resection[xvi, 21, 22]. Similarly to our study, the results of two of these studies observed that CoSeal® tin can reduce the incidence and duration of air leaks[16, 21], whilst in contrast, the 3rd study did not find any benefit conferred by the utilize of CoSeal®[22]. In the first study by Venuta et al.[21], l patients undergoing standard pulmonary lobectomy with incomplete or absent-minded fissures were intraoperatively randomized into two groups: group I received CoSeal®, applied over the newly-designed fissures; group II received no sealants. The groups differed with respect to elapsing of drainage, hospital stay, and presence of air leakage during the first five days. A PAL (>seven days) was nowadays in eight% and 20% of patients in group I and group II, respectively. The authors concluded that the apply of CoSeal® in selected cases may assistance to reduce the incidence and duration of air leaks[21].

The second study past D'Andrilli et al.[16] evaluated the effectiveness and safety of CoSeal® in reducing air leaks in patients undergoing lung resection with reinforcement of the stapled line by bovine pericardial strips in instance of incomplete crevice. In full, 203 patients undergoing anatomic or atypical lung resection were enrolled. Patients showing moderate or severe air leaks were intraoperatively randomized to either the standard care grouping (suture-stapling) or the CoSeal® group (suture-stapling plus CoSeal®). The intraoperative air leak cessation rate was significantly higher in the CoSeal® grouping compared with the standard care grouping. In add-on, the CoSeal® grouping showed a significantly lower rate of air leaks after 24 and 48 h[16]. The application of CoSeal® sealant proved constructive in reducing air leaks and in shortening the duration of PAL.

The 3rd report by Tan et al.[22] evaluated the effectiveness of CoSeal® in reducing the duration of air leaks in patients undergoing lung resection. Patients who experienced an intraoperative air leak during the underwater air-tightness test were randomized to either the CoSeal® grouping or standard care grouping. At 24 h, there was no divergence in air leak between the groups and fewer patients in the control group were leaking at 48 h postoperatively[22].

Possible reasons for the conflicting results of this written report[22] with those of D'Andrilli et al.[16], Venuta et al.[21] and our study, could be due to the inclusion of approximately 40% of the patient poulation in the Tan et al. study with mild (Grade 1) intraoperative air leaks, which ordinarily take a rapid, spontaneous resolution, and differences in the dose of product applied in each patient[23]. Additionally, in contrast to our written report, postoperative air leaks in these studies[16, 21, 22] were detected by an analogical chest drainage system, so air leaks could non exist accurately measured. The detection of air leaks has recently been improved past the addition of digital units to chest drains. The prototype digital breast drain is DigiVent™, which consists of a collection sleeping room, equipped with a unidirectional dry valve, digital displays, and software that can assess and record instantaneous and cumulative air flows and pleural pressures. In our experience, the use of digital chest drain systems in patients undergoing parenchymal resection, or other procedures in which sealants have been practical, has yielded heady results.

In our study, the incidence of air leaks detected by DigiVent™ was significantly lower in patients treated with CoSeal® compared with controls (10.8% versus eighteen.1%, respectively). Moreover, there was a significantly higher incidence of prolonged air leaks in the control grouping compared with the CoSeal® group (11.iv% versus 2.7%, respectively). The mean hospital stay was shorter amongst patients treated with CoSeal® compared with controls, which may translate into associated price savings. In the present study, CoSeal® demonstrated superior air sealing efficacy compared with standard care in patients with expert pulmonary role, showing a significantly reduced proportion of patients with air leaks and lower mean air leak volume.

CoSeal® may be expected to be even more than effective in high-adventure patients who may exist predisposed to fragile, poor quality lung parenchyma (e.k., patients with chronic obstructive pulmonary affliction ([COPD], inflammation or apical fibrosis). However, further stratification of patients is required in order to evaluate the advantages of continuous digital recording of air leaks post-obit sealant awarding in loftier-risk cohorts (e.g. COPD) and patients undergoing upper lobe resections. These studies could too include investigations relating to the extent of parenchymal resection (in terms of suture line length) and the characteristics of staplers. Such studies would provide interesting information apropos the prevention, early recognition and treatment of air leaks in a larger number of patients.

Conclusions

The results of this study advise that CoSeal® is an effective method of reducing postoperative alveolar air leaks, continuously monitored using the DigiVent™ system, in patients undergoing elective lung resection. In our opinion, the utilize of CoSeal® could take a favorable bear upon on patient compliance, as well equally reducing the length of infirmary stays and associated costs.

Abbreviations

COPD:

Chronic obstructive pulmonary disease

CT:

Computed tomography

FEV ₁ :

Forced expiratory volume in one second

LB:

Lower bilobectomy

LLL:

Left lower lobectomy

LUL:

Left upper lobectomy

ML:

Middle lobectomy

paCO₂ :

Partial pressure level of carbon dioxide

paO₂ :

Partial pressure of oxygen

PAL:

Prolonged air leaks

PEG:

Polyethylene glycol

ppoFEV ₁ :

Predicted postoperative FEV _i

RLL:

Right lower lobectomy

RUL:

Right upper lobectomy

UB:

Upper bilobectomy.

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Acknowledgements

Editorial help was provided past Fishawack Communications Ltd (U.k.); this assistance was funded past Baxter BioSurgery, Italy.

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Affiliations

1. Section of Thoracic Surgery, IRCCS-CROB Centro Riferimento Oncologico Basilicata, Rionero in Vulture, PZ, Italy

   Cosimo Lequaglie, Gabriella Giudice, Rita Marasco & Aniello Della Morte

2. Basilicata Regional Health Department, Potenza, Italy

   Massimiliano Gallo

3. Department of Thoracic Surgery, IRCCS-CROB Centro Riferimento Oncologico Basilicata, Via Padre Pio due north° 1, 85028, Rionero in Vulture, PZ, Italy

   Cosimo Lequaglie

Corresponding author

Correspondence to Cosimo Lequaglie.

Additional data

Competing interests

No sources of funding were used to support the study. The authors had full control of the design of the study, methods used, outcome parameters and results, analysis of data and product of the written report. All authors declare that they have no competing interests.

Authors' contributions

CL participated in the blueprint of the report and its coordination and helped to draft the manuscript. GG participated in the pattern of the report and helped to draft the manuscript. RM participated in the design of the report, participated in the sequence alignment and helped to draft the manuscript. ADM participated in the design of the study, participated in the sequence alignment and helped to draft the manuscript. MG performed the statistical analysis. All authors read and approved the final manuscript.

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Lequaglie, C., Giudice, G., Marasco, R. et al. Utilize of a sealant to prevent prolonged air leaks after lung resection: a prospective randomized report. J Cardiothorac Surg 7, 106 (2012). https://doi.org/10.1186/1749-8090-7-106

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• Received: 08 May 2012

• Accepted: twenty September 2012

• Published: 08 October 2012

• DOI : https://doi.org/10.1186/1749-8090-7-106

Keywords

• Air leak
• Surgical sealant
• Digital chest drain

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