| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
|
Interact CardioVasc Thorac Surg 2009;9:1-3. doi:10.1510/icvts.2009.202648 © 2009 European Association of Cardio-Thoracic Surgery
The use of sealants in modern thoracic surgery: a survey
a Division of Thoracic Surgery, Department of Thoracic Surgery and Oncology, National Cancer Institute, Pascale Foundation, Via Semmola, 81, 80131, Naples, Italy Received 13 January 2009; received in revised form 18 March 2009; accepted 18 March 2009
1 Nycomed, Copenhagen, DK.
Key Words: Sealants; Air leaks; Hemostasis; Lung surgery
The indications for the resort to sealants during thoracic surgery are still controversial [1]. The multiplicity of commercially available products, the lack of consistent, irrefutable evidence for their efficacy and the delicate relationship with industry call for a clarification of the status quo within the thoracic surgical community. The results of a survey conducted during the proceedings of a Satellite Symposium taking place during the last 2006 joint EACTS-ESTS meeting in Stockholm are hereafter reported. Two hundred and forty participants to a Satellite Symposium on the use of a specific, commercially available, sealant were asked to anonymously respond through a power-vote system to six multiple-choice questions aimed at establishing the current standards of practice. No additional demographic data nor information on professional experience were required to participate in the survey. The answers were collected via an electronic (‘power vote’) system and displayed by percentage at the end of the questionnaire (see Figures). The analysis of the results was as follows (Figs. 1–3
How often do you use sealants in your practice? The survey clarified that only a minority of surgeons use sealants routinely in their practice (8%). Conversely, 54% use these products only when indicated, while 21% prefer to have sealants available in the hospital for an exceptional use. Worthy of note is that 17% of the participants felt that the use of sealants is limited by their cost.
Which hemostatic method do you routinely use on fragile vascular structures? With regard to the technique of hemostasis of fragile vascular structures, it was obvious that most surgeons would resort to all necessary measures to ensure control of the bleeder, including sealants. However, the traditional methods of hemostasis represented a priority.
Why should we use sealants? Although 49% of the surgeons seemed convinced that sealants do work and recognize that no definitive evidence is available, 34% were uncertain as to their possible clinical usefulness. Not surprisingly, 17% of the surgeons declared their skepticism and their willingness to be guided in the selection of these products by experts from industry.
When should we use sealants? Sealants are used to prevent air leaks in 49% of the patients on fissures but also on bronchial stump after either lobectomies or pneumonectomies. In addition, 13% of the attendees reported to use sealants in an attempt at closing bronchopleural fistulas. While 7% of the surgeons use sealants also on other structures (i.e. pleura), almost one-third of the total showed some degree of versatility by declaring to use sealants for all the above indications.
Which one do you use? For all indications, fibrin glue (30%) and surgical patch combining human fibrinogen and thrombin (46%) were the most used sealants by our survey population. However, 17% of the surgeons could only identify the products by their brand names and not by their main chemical components.
Do you envisage different sealants for different indications or a ‘one-fits-all’ situation? While half of the audience seemed to prefer specific sealants for specific indications, the remaining surgeons either expressed the willingness of deciding based on their own experience (41%) or were not sure and confused by the variety of commercially available sealants (9%). Several randomized studies have been proposed for different, commercially available products, in an effort to confer to the evaluation of the use of sealants the long desired scientific rigorousness [2–9]. Recently, a meta-anlysis has showed the absence of a definitive advantage from using sealants in pulmonary surgery when the end-points are the reduction of in-hospital length of stay and postoperative morbidity [10]. In line with the conclusions expressed by this literature source, only 8% of the respondents to our survey have declared to use sealants routinely. Major criticisms elicited by currently available studies include the lack of a precise methodology, the usually limited numerosity, the deficient information of the relationship between companies and surgeons testing a sealant, and the presence of significant confounding factors (i.e. postoperative air leak assessment). In addition, the definition of costs and reimbursement policies are often a neglected, albeit crucial, point of discussion. With the modern management protocols focused on fast-tracking thoracic patients in order to decrease costs of health care, one wonders whether the simple reduction of hospitalization could still serve as a major clinical goal for wedge resections. Rather, the clinical contribution of sealants should be tested in contexts where the use of sealants may undoubtedly make a difference in the clinical practice, i.e. in association with a no-drain policy following video-assisted sublobar pulmonary resections, such as for lung biopsy, peripheral nodules or spontaneous pneumothorax. A consistent ratio of the procedures commonly performed in the routine in-patient clinical practice could then be reserved for an outpatient setting. As a consequence, the issue of the cost-effectiveness of sealants for preventative air leak control could become less relevant for thoracic surgeons. In fact, only 17% of the respondents to our survey have claimed the costs of sealants to be a determining factor in their clinical decisions. Despite the obvious limitations intrinsic to any survey, this study is meant to serve the purpose to clarify the approach of contemporary thoracic surgeons towards the utilization of sealants. Firstly, a clear distinction is needed between hemostatic agents and air leak sealants, particularly because more than half of the respondents want to apply sealants only when indicated and almost the same percentage feel these adjuncts actually work. While a persistent bleeding is seen as a threatening intraoperative complication which calls for all possible means to stop or control it, in the thoracic surgeons’ mind the presence of air leakage seems far less worrisome. Indeed, De Camp and co-workers have demonstrated that the air-leak phenomenon in severely emphysematous patients may not be related to the surgical technique used [11]. Secondly, according to the survey, there is still a significant percentage of surgeons (17%) who are not aware of the physiologic mechanisms of action of each single sealant. Curiously, it is the same percentage of respondents who would prefer to have guidance in theatre while using different sealants. Thirdly, despite the wide array of commercially available products, the responders seemed to converge on the use of fibrin glue and/or thrombin-fibrinogen patches, currently the most studied sealants in thoracic surgery. Whether the participants to a Symposium sponsored by a Company with a definite interest in the field1 were somehow influenced towards a product preference, it remains to be seen especially taking into account the anonymity of the reply system. However, slightly more than one-third of the respondents replied they used sealants according to their own experience, irrespective of current knowledge in this field. It is our opinion that this survey shows the need for taking the subjectivity out of the assessment of sealants clinical efficacy. When observational data are analyzed, propensity score methods should be routinely used to reduce the so-called ‘treatment-selection bias’ [12]. Alternatively, rigorously conducted, prospective and randomized trials represent the way forward but this may still not be enough. As an example, given the latest technological advancements utilized to objectively quantify air leakage, an empiric determination of persistent air leaks in the setting of randomized trials should not be accepted any longer [13]. Commendable efforts are being made to approach the issue of the use of sealants in thoracic surgery by professional organizations which have been able to produce recently published guidelines aimed at establishing their clinical value in specific clinical scenarios2. However, it is envisaged that, in the future, scientific societies may also offer the intellectual structure and the network of institutions necessary to ensure an impartial organization, performance and evaluation of clinical trials on the usefulness of sealants in thoracic surgery.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| ANN THORAC SURG | ASIAN CARDIOVASC THORAC ANN | EUR J CARDIOTHORAC SURG |
| J THORAC CARDIOVASC SURG | ICVTS | ALL CTSNet JOURNALS |
Top
Question no. 1
Question no. 2